Regulatory Affairs Analyst Resume Sample
Work Experience
- Responsible for the tracking of regulatory findings and open issues across the bank. Prepares comprehensive status reports for the board and management; maintain reporting metrics
- Provides clear and concise communications to regulators and executive and senior management. Serve as a point of contact with the OCC, Federal Reserve Bank of Minneapolis and Consumer Financial Protection Bureau. Uses judgment to determine the appropriate method and content of communications. Participates in communication strategy decision-making
- Works with business line executives to define and clarify regulatory issues and identify resolution strategies. Analyzes the risks presented by open issues and identify issue priority status
- Reviews and analyzes business line communications and management action plans relating to regulatory issues. Recommends enhancements to plans and communications; provide feedback to senior executives
- Participates in meetings with regulators and executive and senior management and keeps records of such meetings. Provides guidance to business line managers on examination management. Works closely with regulators and senior business line managers. Assist with the coordination of regulatory meetings, exams and the fulfillment of regulatory information requests
- Participates in developing and maintaining the enterprise GRC system and electronic storage solutions for regulatory communications
- Prepares department procedures and training materials; maintain department records
- Tracking of regulatory designated employees through key stages in the employee lifecycle
- HR Regulatory program management, including the Staffing Adequacy Framework and HR Control Forums
- Support BARDA Program Office(s) as a subject matter expert in relevant field of experience(s) for vaccine, therapeutic, and/or antimicrobial advanced development; clinical and/or regulatory policy; and/or manufacturing capacity construction
- Provide guidance documents and option papers on key issues related to the area(s) identified
- Review contract proposal and related documents
- Provide senior-level briefing(s) to ASPR/BARDA as required
- Prepare regular reports to ASPR/BARDA management on various technical issues identified
- Provide project development level portfolio management and oversight
- Develop, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts
- Provide subject matter expertise in regulatory affairs supporting MCM development pathways
- Strategize innovative regulatory approaches to MCM development against emerging threats
- Advise regulatory and BARDA senior leadership on critical programmatic and project level regulatory challenges
- Provide training and advisement to BARDA staff on regulations, authoring regulatory documents, and interactions with regulatory authorities
- Producing drafting and research for ORA’s various management reports, both regional and global
- Creating PowerPoint slides to reflect the firm’s policy priorities and objectives
- Provide product and/or regulatory training to clients and business partners
- Provide continuous support across a variety of HR Regulatory programs, primarily focusing on the Staffing Adequacy Framework, HR Control Forums and a suite of processes focused on key stages of the senior employee lifecycle; on point for helping to project manage, execute and monitor end-to-end processes
Education
Professional Skills
- Project or case management experience, or proven organizational skills
- Strong computing skills, including Excel and PowerPoint
- Excellent problem solving and planning skills required
- Strong writing, verbal and interpersonal communication skills
- Excellent interpersonal skills and ability to work collaboratively within a team
- Strong research, analytical, organizational, interpersonal and communication skills
- Work alongside Engineering/Validation during equipment commissioning, validation and conformance manufacture
How to write Regulatory Affairs Analyst Resume
Regulatory Affairs Analyst role is responsible for interpersonal, languages, regulatory, english, powerpoint, excel, planning, database, trading, telecommunications.
To write great resume for regulatory affairs analyst job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Regulatory Affairs Analyst Resume
The section contact information is important in your regulatory affairs analyst resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Regulatory Affairs Analyst Resume
The section work experience is an essential part of your regulatory affairs analyst resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous regulatory affairs analyst responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular regulatory affairs analyst position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Regulatory Affairs Analyst resume experience can include:
- Create materials, typically PowerPoint decks, to illustrate concepts and/or assist in coaching partners to continuously manage/guide the process forward; maintain materials so they are kept “live”
- Provide analytic support to aggregate and summarize complex data sets, working in Business Objects, Excel and PowerPoint to present information in a clear and succinct manner
- Help to maintain regulatory data in various HR systems, including uploading and quality checking data, working on system enhancements and providing support to HR colleagues
- Manage several tracking and quality control mechanisms, typically in Excel (e.g., scope, key deliverables, documentation); partner with HRBPs and key stakeholders to keep these green and on track
- Effectively prioritize and multi-task in a fast-paced environment
- Experience in preparing DMFs, specifically eCTD submissions is desirable
Education on a Regulatory Affairs Analyst Resume
Make sure to make education a priority on your regulatory affairs analyst resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your regulatory affairs analyst experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Regulatory Affairs Analyst Resume
When listing skills on your regulatory affairs analyst resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical regulatory affairs analyst skills:
- Effectively communicates both verbally and in writing
- Additional language skills (Japanese, Spanish, Portuguese, Mandarin, Arabic)
- Work in a matrix organization and participate effectively both independent and as part of multiple teams
- Experience drafting and filing documents using SERFF
- Skilled in planning, organizing, coordination projects and working independently
- Experience interacting and collaborating with a variety of stakeholders (other team members, internal customers and executives)
List of Typical Experience For a Regulatory Affairs Analyst Resume
Experience For Senior Regulatory Affairs Analyst Resume
- Experience in communicating with customers, suppliers, other departments, and senior management on complex issues
- Experience in IVD (In Vitro Diagnostic), or Medical devices industry in Regulatory or Quality,
- Experience in a company start-up environment, preferably in medical devices or combination products
- Working in collaboration with the health plan operations department
- Communicating with domestic and international business partners and direct interaction with regulatory agencies on product issues and questions
- Responsible for creating and filing products for UHC fully insured plans in NV, including binder filings
- Maintain global product regulatory compliance by reviewing design changes, labeling, advertising and promotional materials
- Monitors competitor advertising to keep abreast of market promotional and advertising strategies
Experience For Corporate HR Regulatory Affairs Analyst Resume
- Is accountable for ensuring the Plan compliance with newly issued regulatory notices
- Reviews and approves all new formulations/labeling for local and global compliance
- Generates Origin, Animal testing, Allergens, CMR/Nano, Gluten Free, BSE and other requested statements upon review of formula or ingredients
- Ensures archiving of activities, especially submissions, internal memos and key correspondence
- Keep tracking on Regulatory submission/approvals
Experience For Enterprise Compliance & Regulatory Affairs Analyst Resume
- Documents and information sharing with others areas (SAC, tenders, MKT, SJC Technical RA)
- Conducts trend analysis with respect to new and emerging regulatory trends
- Collaborates with Corporate Compliance and Corporate Audit to provide research and regulatory compliance monitoring support
- Conducts research for the operating divisions and Law Department attorneys as requested
- Participates in company and industry committees and working groups as required
- Develops productive working relationships within Pacific Life and with industry peers and trades
Experience For Regulatory Affairs Analyst, Post Market Resume
- Read, review, interpret and keep current with regulations, recognized standards and publications regarding drug and device products
- Interact with B. Braun representatives of foreign countries regarding registration of drug and device products
- Interact with regulatory agencies concerning regulatory filings with minimal supervision
- Provide regulatory guidance to interdepartmental members concerning B. Braun filings
- Review labeling for accuracy and compliance with regulations
- Respond to inquiries, requests and actions by regulators, including complaints and requests for assistance
- Complete internal regulatory review and filings related to marketing materials
- Coordination of on-going regulatory activities with Corporate Quality and Regulatory Affairs
Experience For Quality & Regulatory Affairs Analyst Resume
- Monitors policies procedures and standards relating to Regulatory Affairs, evaluates impact and communicates to affected parties
- Participation to the review of labeling components
- Administrative maintenance of all regulatory documents incl. their archiving
- Official Gazette monitoring
- Give support in submissions of new products, variations and renewals on the National Sanitary Authorities of Uruguay, regarding imported and local products
- Give support in submission about on our Manufacturing Site
- Provide technical support to departments regarding current, proposed and newly promulgated regulations
- Review program documentation and provide thoughtful, consistent feedback from a centralized and regulatory perspective
- Develop position and productive relationships with business line partners
Experience For Regulatory Affairs Analyst, Senior Resume
- Personally attend hearings and present the Plan’s position to an Administrative Law Judge (ALJ) at the hearing offices in downtown Brooklyn, attend hearings via telephone for the rest of NYS, and support the team in complying with Fair Hearing decision
- Independently investigates and responds to inquiries, concerns, and information requests presented by DHS, other regulatory agencies, and State legislators
- Leads contract compliance initiatives implemented in response to DHS-identified issues/concerns
- Provides strategic direction, tactical and regulatory expertise to internal workgroups, and clearly articulates DHS expectations to the Plan
- Advocates on the Plan’s behalf to obtain DHS approval of Plan initiatives and to mitigate any disciplinary actions, i.e. sanctions or corrective action plans
- Independently represents the Plan in meetings with state agencies and consumer advocates
- Represents the Director, Regulatory Affairs in interactions with internal and external stakeholders. Provides guidance and oversight to Regulatory Affairs team in Director’s absence
- Advanced user in Microsoft office and internet
Experience For Associate Regulatory Affairs Analyst Resume
- Provide product information to worldwide peers for product introductions and changes. Provide product test information to support international submissions
- Provide project and administrative support for customers within Global Regulatory Affairs, as well as regional and country regulatory affiliates
- Works in close collaboration with internal stakeholders and supports multiple projects
- Provides high quality global support for all marketed products through global expansion efforts and maintenance of approved products
- Partners with regions to assess and support documentation needs (e.g., certificates)
- Ensures compliance with global regulatory requirements and adherence to internal policies and processes, and coordinates compliance activities at a global level
- Provides support as needed for non-project related regional excellence activities
Experience For Corporate & Investment Bank Office of Regulatory Affairs Analyst Resume
- Coordinates regulatory filings and proceedings
- Leads and plans docket team meetings, develops project timelines, reviews petitions and testimony, manages discovery, summarizes key milestones, and attends hearings
- Assists with the management and execution process for international registrations including providing guidance with localization and labeling requirements
- Works with Customer Service team with complaint handling, analysis and regulatory reporting requirements (US and international)
- Participates as needed in field actions including assisting with the creation of plans and reports, action execution, and regulatory agency interaction
Experience For Assoc Regulatory Affairs Analyst Resume
- Focus on and achieve scheduled milestones, including contingency planning
- Generates and coordinates regulatory submission documents for new products or changes to existing health authorities' filings
- Determines governmental regulations affecting company processes and assures the processes are complete and accurate to ensure company compliance
- Partners with various teams throughout organization (Marketing, Promotions, Operations, R&D, Quality, etc.) on projects
- Knowledge of FDA, CA-FDB, and ISO regulations/standards, including ISO 10993 (requirements for biocompatibility)
Experience For Compliance Regulatory Affairs, Analyst Resume
- Monitors state and national regulatory proceedings and provides timely summaries to leadership
- Masters standard concepts, practices, and procedures of the state’s regulatory proceedings
- Writes, submits, and coordinates new product notifications, CE Mark Technical Files/Dossiers, Investigational Device Exemptions and international regulatory submissions in various countries
- Acts as team expert for promotional materials review, experimental designs, data analysis, and product labeling as they relate to registration and commercialization of Cool Sculpting devices
- Works with clinical team to assure appropriate organization and data are used for regulatory submissions and clinical presentations
List of Typical Skills For a Regulatory Affairs Analyst Resume
Skills For Senior Regulatory Affairs Analyst Resume
- Highly effective communication and analytical skills
- Highly effective communication and analytical skills – able to interface with internal and external customers across multiple business functions
- Good communication skills, both written and verbal (in English)
- Related experience; or any combination of education and experience, which would provide an equivalent background
- Generally requires 5-7 years related experience or equivalent combination of graduate-level education and experience
- Fluency in English as business language, basic conversational skills in German required, additional languages advantageous
Skills For Corporate HR Regulatory Affairs Analyst Resume
- Prior regulatory or government work experience
- Work experience in a banking, lending, audit or compliance-related environment
- Experience responding to formal requests for information from state and federal healthcare oversight agencies
- Experience with proper handling of sensitive personal health information
- 6+ months of experience working in health insurance and/or managed care, Medicare, or Medicaid
- Experience responding to inquiries from a variety of stakeholders (external customers, internal customers, executives and regulators)
- Experience communicating complex information via phone conversations and emails to non-technical clients, external customers, internal customers and executives
- Experience working in health care, managed care and/or health insurance
- Experience with regulatory affairs, compliance or licensing
Skills For Enterprise Compliance & Regulatory Affairs Analyst Resume
- Experience working in a regulatory affairs or related function
- Experience working with insurance contracts, policies and/or certificates
- Advanced experience performing online research; specifically around state statutes and regulations
- Intermediate level of experience working with Microsoft Word
- Experience in the health insurance/health maintenance organizations industry or a background working with a State Insurance Department
- Electronic filing experience with the states (SERFF)
- Experience in a health care regulatory environment (managed care, forms filing, product development, and/or compliance expertise)
- Experience researching laws and regulations with Lexis/Nexus/NILS
Skills For Regulatory Affairs Analyst, Post Market Resume
- Previous audit experience (IT audits, SOX and PCI)
- Friendly, good attitude and customer service oriented
- Multi-task and prioritize projects to align with department and organizational objectives
- Experience with mechanical and electrical medical devices
- Review art works of packaging and promotional materials prior to the signature by the Technical Director
- Strong dedication to customer service and completing assignments
- No directly related experience required
- Experience in the medical device industry or regulatory affairs
- Regulatory Affairs experience in the clinical research industry
Skills For Quality & Regulatory Affairs Analyst Resume
- Experience in a health care regulatory environment
- One (1) or more years of experience in Regulatory Affairs
- Multitask and prioritize under moderate workload with some supervision
- Experience in a health care regulatory environment; managed care, and/or compliance expertise
- Demonstrated ability to analyze and understand complex issues
- Experience in the local regulatory affairs in multinational companies (not mandatory)
- One to two years experience in Regulatory Affairs or scientific discipline
- Work with Manager of Regulatory Affairs, Government Affairs staff, trade associations and regulatory agencies to set priorities
- Experience in preparation of regulatory filings in pharma or medical device settings
Skills For Regulatory Affairs Analyst, Senior Resume
- Training in Quality Systems including QSR, ISO/CE marking
- Understanding of the issues facing NYPA and the electric utility industry and the ability to express complex technical and legal concepts
- Understanding of the process by which the organization develops and issues rulings, regulations and other legal directives
- Working knowledge of excipients and CMC requirements for cell and gene therapies is desirable
- Assist in creating training materials and facilitating various training programs
- Comprehensive understanding of manufacturing processes, chemistry and engineering principles
- Provide manufacturing support and direction to Engineering team, reviewing drawings, equipment specifications, facility design, etc
- Knowledge of existing and emerging regulations, standards or guidance documents
Skills For Associate Regulatory Affairs Analyst Resume
- Innovation:Influence the groundbreaking technologies that are revolutionizing the dental orthodontics industry
- Knowledge of banking and lending
- Act as a “subject matter expert” for inquires and materials, including serve as “go to” contact, working closely with various HRBPs and other key partners
- Technical background in engineering or biological/physical sciences
- Reviews regulatory rulemaking and guidance from a variety of sources to remain current on Industry rules
- Direct and oversee short-term and long-term planning of regulatory submission initiatives
- Review and change ongoing projects as needed
- Coordinate and prepare document packages for regulatory submissions ensuring compliance with the Food and Drug Administration
- Interpret and summarize information from multiple sources including regulations, health authority guidance’s, and internal documents
Skills For Corporate & Investment Bank Office of Regulatory Affairs Analyst Resume
- Support writing of technical transfer plan / final report
- Ensure alignment with plant manufacturing strategies, policies and procedures for design of equipment / facility in new / renovated areas
- Assist with regulatory research and reporting
- Broad knowledge of broker-dealer operating practices and more specifically rules and practices relative to areas of responsibility
- Proficient in Microsoft Office and applicable web tools
- Knowledge of laboratory regulatory environment (CAP, NYS, NLCP)
Skills For Assoc Regulatory Affairs Analyst Resume
- Knowledge of LabCorp legacy systems (LCLS, LCBS)
- Committed to continuous improvements in quality
- Assertive and not afraid to ask questions
- Familiarity with domestic and international regulations, standards and guidance documents
- Keep up with a fast-paced environment
- Positive attitude and embraces constructive change
- Assertive, not afraid to ask questions
- Strategic minded, analytical and detail oriented
Skills For Compliance Regulatory Affairs, Analyst Resume
- Validates and analyzes data, documents, and information delivered to regulatory entities. Ensuring accurate data delivery to the inquiries for all business lines including requests from SEC, FINRA, MSRB, CBOE, Federal Reserve, FDIC or other bank and securities regulatory bodies
- Compliance liaison and compliance expert pre, post and during regulatory inquiries and examinations of the firm and its affiliates including gathering documents, completing questionnaires surrounding the firm’s business, attend meetings with various departments
- Analyze reports and data across multi-products/processes
- Gathers applicable documents and drafts responses to routine and in-depth regulatory inquiries, including sweeps, regarding the firm’s and affiliate’s business, policies and/or procedures within stated deadlines
- Works with other departments, including senior managers and legal counsel, to resolve issues noted in regulatory examinations, drafts responses to regulatory examinations and performs follow-up to ensure deficiencies are corrected
- Corresponds and interacts with regulators and various business units throughout the Firm and its affiliates; including trading desk staff, bankers, research analysts, Financial Advisors, Branch Managers, home office operations and managers and the Legal Department
- Preparation of GMP Certification process according to ANYTSA regulations
List of Typical Responsibilities For a Regulatory Affairs Analyst Resume
Responsibilities For Senior Regulatory Affairs Analyst Resume
- Strong knowledge on Biological Products
- Experience within the insurance or financial services industry desired
- Partner with Fannie Mae business units to facilitate timely responses to and effective relationships with our regulators
- Handling incoming and outgoing correspondences, including archiving
- Define Europe Region filing strategy (including CP, MRP, DCP); identifying risks and issues
- Primary lead in drafting, filing and obtaining approval of state-specific member and employer documents
- Competent using office software including MS Word, Excel, Internet Explorer, PowerPoint, and Outlook
Responsibilities For Corporate HR Regulatory Affairs Analyst Resume
- Background in regulatory affairs, manufacturing, marketing, or quality assurance sufficient to understand how products are produced and marketed
- Participate in internal working groups as required and address any regulatory actions with Senior RA colleagues
- Preparation/update and submission of packaging components for registered products
- Keep tracking on Regulatory submissions/approval
- Determines international regulatory requirements and develops plans to comply with national laws in each country
- Strong team-working and communication skills. A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed
- Travel, up to 5%
- Reviews new product labeling for accuracy and for other legal/regulatory requirements and communicates planned/approved changes with other functions, including but not limited to operations, medical affairs and commercial teams
Responsibilities For Enterprise Compliance & Regulatory Affairs Analyst Resume
- Reviews advertising and promotional pieces for accuracy and for other legal/regulatory requirements and communicates planned/approved changes with other functions, including but not limited to medical affairs and commercial teams
- Provides regulatory guidance regarding advertising and promotional material, new campaigns and launch strategies
- Supports ad hoc regulatory activities as required
- Generates ingredient list (IL), Quantitative & Qualitative (Q&Q), and Cosmetic or OTC formulation assessments
- Acquires necessary regulatory documentation from Raw Material suppliers
- Acts as Lead Liaison between regulatory bodies and other governmental agencies
Responsibilities For Regulatory Affairs Analyst, Post Market Resume
- Provides insight and systems to formulators to create global and local compliant formulations
- Prepares and submits product dossiers for cosmetic registration and responds to other regulatory questions as needed
- Monitors FDA and FTC activity (ie enforcement, guidance documents, etc.) to analyze and assess impact on SkinMedica products
- Provides status updates to management
- Notifies relevant cross functional team members of regulatory activities, as appropriate
- Draft policy forms, researches mandates, composes or gathers other content, and completes reports to meet state mandates, regulator objections and inquiries; and maintains relationships with state reviewers
- Perform procedures for: control and dissemination of regulated documents; tracking/storage of filings, approved forms, licensure information and reports; and communication of related mandates
Responsibilities For Quality & Regulatory Affairs Analyst Resume
- Provide compliance support to other business areas including advertising review, inquiry response, project participation, research, policy form interpretation, problem resolution and maintenance of information sources on related mandates
- Assure the Artworks for packaging materials are aligned with the finished product
- Maintain the local product files in line with current registered authorization details according to the relevant local legislation
- Support or coordinate state regulatory examinations, surveys and data calls
- Support strategic initiatives to improve local productivity and reduce cycle times primarily for the Registrations, renewals and PACs processes
- Perform a regulatory process including preparation of documents for New Registrations, Renewals and PACs submission, follow up before the Agency and notification of approval letters
Responsibilities For Regulatory Affairs Analyst, Senior Resume
- Ensure that the regulatory systems, ORION (On Line Regulatory information), USPT database are updated with the submission/approval dates in a timely manner
- Support tenders Regulatory Documents (GMP certificates, Bioequivalence letters and others)
- Support the others regulatory process as required by the Manager
- Maintain product license in compliance with market supply, and local authority expectations. Ensure alignment with all applicable change control documents
- Maintain appropriate archive (electronic documentation or paper) to ensure that work is traceable and complies with all appropriate regulations
- Prepare, track and support regulatory activities related to Company Public Private Partnerships (PDP)
- Establish connection with different teams related to PDPs (Global RA, PDP Project Manager and partner) to cascade accurately regulatory information, submission plans and requirements
- Reply HA queries timely
Responsibilities For Associate Regulatory Affairs Analyst Resume
- Ensure deadlines for different projects are met or escalated to Regulatory Manager and/or Director of RA
- Regulatory Evaluation of New Business Opportunities in a Teamwork with New Business Marketing Group (registration feasibility and scenario, matrix go/no go, due diligence, etc)
- Artwork review/approval prior implementation
- Request in the appropriate websites certificates, legal docs for new products (when the regional office is not responsible) and variations submissions
- Keep internal websites updated
- Group discussion participation and regulations study
Responsibilities For Corporate & Investment Bank Office of Regulatory Affairs Analyst Resume
- GMP/CoPP request and management for tenders
- Contribute to compliance with all regulatory requirements (e.g. timely submission of dossiers, timely implementation of new national and international legislation, timely implementation and training of SOP’s & supporting systems …)
- Maintain an awareness of regulatory guidelines/directives/national requirements
- Send spontaneous queries to the appropriate person
- Flexible, able to work under strict timelines
- Affinity with pharmaceutical product development
- Knowledge of relevant IT-systems
- Availability to work in Sao Paulo- SP
Responsibilities For Assoc Regulatory Affairs Analyst Resume
- Monitors the regulatory landscape and identifies changes that impact the Company’s operations - including new or revised legislation/regulation and market conduct activity; communicates new regulatory developments to impacted area(s)
- Engages with Government Relations to provide research and support for policy development and advocacy efforts
- Works with team members to develop and maintain trackers and regulatory resources for use within the Company
- Understand and apply regulatory requirements to achieve regulatory compliance
- Interface with all levels both within and outside the organization
- Highly motivated team player with a collaborative, consultative and innovative approach in the workplace
- Organize and manage projects with a regulatory impact
- Draft and disseminate communications both internally and externally related to regulatory inquiries
Responsibilities For Compliance Regulatory Affairs, Analyst Resume
- Develop strategies to ensure compliance and full cooperation regarding regulatory related requests for business information to ensure timely delivery of key documents to FHFA and regulatory agencies
- Assist in managing and analyzing multiple ongoing special projects involving regulatory or business related issues that could have significant impacts on the company. Many projects would have short deadlines, be completed in a face-paced environment, and require collaborative work within cross-divisional teams
- Develop and oversee tracking and reporting of regulatory inquiries and requests both internal and external to Fannie Mae and provide support to business teams in the coordination and resolution of open inquiries/requests
- Experience in dealing with complex product issues and working across multiple functions and locations to meet requirements and goals
- Ensures timely preparation of organized and scientifically valid pre-market regulatory submissions for all geographies
- Identify, escalate and resolve issues and conflicts and support the company?s efforts to meet its goals and objectives