Regulatory Affairs Associate Resume Sample
Celestine Rowe
3174 Casper Causeway,
New York,
NY
+1 (555) 660 2416
Work Experience
Regulatory Affairs Associate
09/2016
-
PRESENT
Chicago, IL
- Blue Sheet inquiries: enter data into Firm’s system, research options, approve all inquiries via Electronic Blue Sheets Management System, maintain strict timeline for entry and approval of Blue Sheet inquiries, print and maintain daily Blue Sheet entry records for audit purposes and adhere to document retention schedule per industry guidelines
- Understand the company’s products, surgical techniques and the use of implants and other devices
- Build, compile and publishing activities associated with generating hard copy and electronic submissions
- Maintain US and ex-US submission files and logs
- Manage technical aspects of assigned submissions and provide status updates
- Maintain proactive/current awareness of regulations and guidelines pertaining to submission activities
- Publish documents in eCTD format using software tools
Senior Regulatory Affairs Associate
06/2011
-
08/2016
New York, NY
- Troubleshoot document issues in MS Word and Adobe Acrobat Pro
- Assist with development and management of non-routine projects as applicable in support of the Regulatory Affairs department
- Understands business environment and relates extensive knowledge of internal and external activities to trends
- Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units
- Acts as a mentor to less-experienced staff
- Erroneous decisions or recommendations would typically result in failure to achieve organizational objective
- Timely preparation and approval of country records and related attachments on behalf of the Marketing Authorisation Holder (MAH) or representative
- Archiving all relevant submission and approval documents
Global Regulatory Affairs Associate
01/2007
-
02/2011
Phoenix, AZ
- Documenting import, handling and approval
- Setting-up of local records and continuous updates throughout submission approval process
- Monitor applicable global regulatory and labeling requirements; assure compliance with Baxter and external standards and help drive implementation across functions and projects.
- – 15% domestic and international travel as required
- Submission work can involve lifting multiple volumes each weighing approx. 5 pounds
- Interact with Research & Development, Quality Assurance/Quality Control (QA/QC), and Production for gathering data and documentation for submissions
- Review and audit data submitted by technical departments (R&D, QA/QC) and outside firms
- Assist in developing draft labeling for proposed and existing drug products
Education
Grand View University
2002 - 2007
Bachelor's Degree in Life Sciences
Professional Skills
- Negotiation & communication skills; Interpersonal skills; Presentation skills
- Demonstrated strong negotiation and problem solving skills; excellent communicator, ability to multitask
- Superb interpersonal skills and excellent oral and written communications skills
- Good oral and written communication skills along with demonstrated team skills
- Strong problem solving and analytical skills supported by excellent attention to detail
- Strong organization skills and ability to prioritize work load
- Excellent interpersonal and communication skills, ability to work effectively with cross-functional teams
How to write Regulatory Affairs Associate Resume
Regulatory Affairs Associate role is responsible for interpersonal, computer, organizational, regulatory, organization, technical, negotiation, english, research, planning.
To write great resume for regulatory affairs associate job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Regulatory Affairs Associate Resume
The section contact information is important in your regulatory affairs associate 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 Associate Resume
The section work experience is an essential part of your regulatory affairs associate 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 associate 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 associate position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Regulatory Affairs Associate resume experience can include:
- Excellent oral and written communications skills required. Organization skills in prioritizing and managing multiple projects
- Excellent communication skills and ability to effectively present scientific data both in writing and verbally to management
- Demonstrates effective, self-sufficient communication skills, especially in peer-directed presentations
- Communication skills to effectively build relationships with key clients, stakeholders and members of government departments
- Excellent written and spoken communications skills, with confidence in building strong scientific justifications
- Excellent planning, organizational, analytical, problem-solving, proofreading, and decision-making skills
Education on a Regulatory Affairs Associate Resume
Make sure to make education a priority on your regulatory affairs associate 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 associate 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 Associate Resume
When listing skills on your regulatory affairs associate 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 associate skills:
- Accomplished interpersonal skills to work effectively in a team environment and act as a liaison with other departments
- Negotiation and communication skills to effectively build relationships with key clients, stakeholders and members of government departments
- Experience and comfort working independently and as part of a team on multiple projects with ability to prioritize effectively
- Complying with constantly changing regulatory procedures; reprioritizing work effectively
- Possess strong written and verbal communication skills and advanced word processing and formatting
- Very good negotiating, communication and influencing skills
List of Typical Experience For a Regulatory Affairs Associate Resume
1
Experience For Senior Regulatory Affairs Associate Resume
- Strong interpersonal skills in the areas of written and verbal communication
- Strategic mindset and effective collaboration skills
- Participate in cross-functional project teams and work effectively with multiple disciplines and personalities
- A solid track record of global Regulatory Affairs experience within Medical Devices
- Work effectively with cross-functional teams representatives for assigned projects
- Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the client to ensure approval and product supply continuity
2
Experience For Regulatory Affairs Associate Director Resume
- Capable of preparing and presenting effective technical reports and analyses
- Review/approve labeling for OTC, Rx solid oral dosage products
- Review and validate at country level promotional material with Marketing and Medical in line with Global strategies and policies
- Support the consolidation and provision of regulatory expertise and giving input about requirements and needs
- Good understanding of current TGA Regulations and relevant ISO standards associated medical device registration process
3
Experience For Global Regulatory Affairs Associate Resume
- Strong working knowledge of Quality sections of the Common Technical Document (CTD) submission structure
- Good working knowledge of the electronic CTD (eCTD)
- Experience with compiling CMC sections of NDAs in eCTD format and submission to FDA via the Electronic Submission Gateway (ESG)
- Experience interacting with a dynamic team and also be able to work independently
- In-depth and demonstrated knowledge of the Australian and New Zealand regulatory environment and sound understanding of overseas regulatory environment
- Assist in the review of advertising and promotional items in line with the Therapeutic Goods Act and Regulations
- Maintain and update regulatory status of existing medical device products on the Australian Register of Therapeutic Goods
- Experience in registration and maintenance of technical documentation
4
Experience For Regulatory Affairs Associate for Operations Resume
- Regulatory experience in the areas of Biocidal Products and Chemical Legislations
- Effective communication in a variety of mediums
- Experience w/ Material & Device Master Files, regulatory documentation prep, submissions, filings, etc
- Experience in regulatory affairs or related field
- Build strong relationships with key stakeholders, including regulatory commissions and state energy officials
- Regulatory affairs experience with medical devices
5
Experience For Clinical Regulatory Affairs Associate Resume
- Regulatory affairs experience with PMA approved devices
- Experience with FDA and EU regulatory submissions
- Implement and maintain UDI identifiers and/or labeling and manage and maintain GUDID upload to FDA system to ensure regulatory effective dates are met
- Experience in different regulatory classifications (where appropriate)
- People management experience would be advantageous but not essential
- To establish and maintain good relationship with Department of Health officers to facilitate the approval and registration processes
6
Experience For Principal Regulatory Affairs Associate for Medical Devices Resume
- Experience with Canadian consumer and industrial product regulations
- Preparing and/or monitoring formatting of registration files in accordance with the Israeli MOH requirement and guaranteeing their quality
- Preparing packaging material for new products and updating packaging material for old products to be in line with MoH and Pfizer requirements
- Remediating outcomes from gap analysis, clearly communicating Regulatory plan, and presenting final findings to management
- Obtaining licenses and marketing approvals of new products and line extensions
- Handling variations approval according to Pfizer and Local regulations procedures
7
Experience For Regional Regulatory Affairs Associate Resume
- Managing the transfer of licenses to Pfizer following integration or acquirement of a pharmaceutical company
- Supervising and supporting distributors
- Providing pharmaceutical scientific guidance to marketing and sales departments
- Receiving approval from Appointed Pharmacist for all new and updated packaging materials
- Providing expertise, understanding, and guidance on potential global regulatory growth drivers in new strategic applications and industries
- Authoring and updating Safety Data Sheets and other regulatory documentation and certificates
- Completing routine and non-routine internal or external EHS compliance/ conformance testing, reports and associated data analysis
- Handling new Drugs and line extensions process
8
Experience For Regulatory Affairs Associate Support Resume
- Understanding the registration process in Israel, appreciate at what stage the
- Keeping all licenses current and renewed at designated compliance
- Managing Medical Information queries responses
- Working Knowledge of Australian and New Zealand regulatory requirements for medical device registrations
- Providing product-related quality information to other departments, authorities, consumers, health care professionals and trade associations
- Monitoring of regulatory approvals
- Maintaining registered products
- Working knowledge of device 510(k) CMC-related requirements desirable
- Providing answers to any questions raised by the Ministry of Health
9
Experience For Post-market Regulatory Affairs Associate Resume
- Working knowledge of the study protocols and procedures
- According to REG -01
- Supporting business with Life Cycle Management and RM processes
- Evaluating change controls and provide the regulatory assessment
- Ordering and collection of relevant documents together with relevant stakeholders, as per defined regulatory strategy
- Working with PV on PSUR submissions and SmPC updates
- Authoring of safety data sheets, labels, and transportation documents, and regulatory functions
- Reviewing global quality documents across Pfizer sites and perform gap analysis
- Including assuring the regulations and laws regarding IND submissions and financial disclosure meet compliance
10
Experience For Regulatory Affairs Associate / Project Leader Resume
- Liaise with HA contact person; organizing and preparing HA meeting and attending as appropriate
- Keep current with the FDA/ICH regulations pertaining to GDUFA, CMC and regulatory filing aspects by independent learning, attending conferences and symposiums
- Coordinate dossier and briefing package preparations according to the plans (new registration and maintenance) and monitoring dossiers up to implementation
- Work within the team to proofread established labeling files for content accuracy either manually or by utilizing the electronic proofreading tool TVT
- Provide CMC Regulatory support as needed through the authoring/co-authoring/review of CMC sections of the following types of Regulatory submissions
- Prepare regulatory documents for submission to the FDA, including writing, publishing, correct placement in eCTD hierarchy
- Support the QMS training program, including applicable QMS and regulatory requirements
List of Typical Skills For a Regulatory Affairs Associate Resume
1
Skills For Senior Regulatory Affairs Associate Resume
- Strong oral and written communication skills; technical writing skills
- Good written and verbal communicator with excellent interpersonal skills
- Demonstrates problem solving and interpersonal skills through effective interactions with team members
- Good organizational skills and an ability to manage multiple tasks/projects/priorities and complex systems simultaneously are required
- Strong collaboration skills and experience working in teams
- Demonstrated computer skills and strong written and verbal communications
- Excellent verbal, technical writing, organizational, and communication skills
- Analytical mind, good attention to detail and problem-solving skills
- Experienced in new chemical notifications to NICNAS and NZ EPAGood understanding of dangerous goods (IATA, IMO, ADG) in relation to chemical products
2
Skills For Regulatory Affairs Associate Director Resume
- Excellent interpersonal and intercultural communication skills, both written and verbal
- Solid computer and documentation skills
- Strong interpersonal skills to take care of sensitive and occasionally contentious issues
- Uses effective communication and employs influencing skills to establish key relationships with internal/external contacts
- Good strategic and decision-making skills
- Strong communication (verbal, written, listening) and interpersonal skills with the ability to communicate cross-functionally in a collaborative manner
- Good level of pharmaceutical industry understanding, with demonstrated experience within the EU regulatory environment
- Good computer skills with working knowledge of MS office such as Word, Excel, Outlook and Adobe Acrobat Professional
- Independent, proactive and optimistic personality with strong problem solving skills
3
Skills For Global Regulatory Affairs Associate Resume
- The ability to achieve business priorities using exceptional organisation and planning skills
- Prior experience in the research or pharmaceutical industry or project management experience
- Excellent interpersonal, teamwork and verbal/written communication skills are required
- Good organizational, analytical, problem solving and decision making skills
- Communicating effectively with the manager, medical writing on progress made and issues/problems raised
4
Skills For Regulatory Affairs Associate for Operations Resume
- Negotiating, communication and interpersonal skills
- Word processing skills, including Microsoft Word, Excel and PowerPoint
- Detail-oriented; strong written and verbal communication, including proof-reading; excellent organization
- Analytical and writing skills
- Strong sense of planning and prioritization, and the ability to work with all levels of management
- Experience gained working in worldwide markets, with a proven record of achievements
- High level report writing skills
5
Skills For Clinical Regulatory Affairs Associate Resume
- Prior experience in US-FDA (OTC monograph) and/ or European Biocides
- Strong ability to multi-task, organize and prioritize
- Work with people from various disciplines and cultures Cognitive Skills or Ability to
- Mastery of English language (written and oral) communication skills as well as local language where applicable
- Outstanding analytical, investigative and problem-solving skills
- Sharp executive presence and consultation and presentation skills
- For all assigned documents and other projects, provide medical writing support and work effectively with project teams, as indicated by
- Awareness of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) as they apply to a pharmaceutical research and production environment
6
Skills For Principal Regulatory Affairs Associate for Medical Devices Resume
- Experience working within Regulatory Affairs (CMC) with a strong background in the generic pharmaceutical industry
- Applied analytical and problem-solving skills
- Prior experience within a regulatory or quality role
- At least six (6) months experience in regulatory affairs experience or in a regulated industry
- Demonstrate model behavior, understand priorities and encourage others to drive for results
- Critical decision making and troubleshooting skills
- Demonstrated experience in preparing new IND, NDA and/or BLA submissions
- High technical and organizational skills
7
Skills For Regional Regulatory Affairs Associate Resume
- Communicating and negotiating with regulatory authorities and stakeholders under supervision of more experienced RA team-members
- Keeping valid import licenses for all Pfizer Pharmaceuticals Israel products
- Working knowledge of Good Clinical Practice and US FDA regulations related to medical device clinical studies
- Experience w/ independently authoring, compiling, and reviewing ANDAs, NDAs, Amendments, Supplements, and Annual Reports for submissions
- Experience creating and maintaining electronic documents, preferably using Microsoft Office
- Experience in regulatory affairs, including clinical and labeling submissions
- Would benefit from experience using AW management systems (GMPS, etc.) and adhering to relevant SOPs and processes
8
Skills For Regulatory Affairs Associate Support Resume
- Strong attention to detail, resilience and an ability to bring innovative ideas to problem solving
- Experience of CMC Module 3 chemistry manufacturing control regulatory writing
- Clinical nursing experience
- Experience with 510(k) submissions and CE Marking
- Strong independent research capabilities using available paper and electronic resources
- Excellent understanding of drug development and of the Canadian regulatory environment and Health Canada regulations, policies and guidelines
9
Skills For Post-market Regulatory Affairs Associate Resume
- One (1) year or more of relevant industry experience or equivalent education/training
- Experience in managing the preparation and compilation of regulatory submissions is required
- Develop and/or maintain a good working knowledge of relevant regulatory guidelines and procedures
- Demonstrates knowledge and understanding of applicable regulations
- Experience working in Regulatory Affairs
- Develop good working relationships with regulatory bodies, distributors, customers and colleagues
- Review/approval of engineering study protocols/reports and validation study protocols/reports
- Experience working on an NDA team (preferably for an oncology product)
- Experience leading the development of an IND
10
Skills For Regulatory Affairs Associate / Project Leader Resume
- Strong ability to problem solve and apply analytical thinking
- Good understanding of guidelines and regulations
- Extensive experience working in a cGMP regulated environment
- Knowledge of regulations and guidelines that govern clinical research, including but not limited to FDA regulations and Good Clinical Practice
- Significant regulatory & change management experience covering medical devices and/or pharmaceuticals
- Experience in design control process - i.e. product development; Knowledge of advertising and promotion regulations for healthcare products
List of Typical Responsibilities For a Regulatory Affairs Associate Resume
1
Responsibilities For Senior Regulatory Affairs Associate Resume
- Copes with changing priorities and a demonstrated ability to prioritize multiple projects
- Excellent French and English written and oral communications skills
- Able to work in a cross-functional environment with strong management skills
- High level of organizational skills and prioritizing
- Good written, communication, project management and presentation skills
- Strong interpersonal, collaborative skills
- Strong Excel skills for data analysis
- Excellent computer Skills (Excel, PowerPoint and word)
- Good written and verbal communication, presentation, and facilitation skills
2
Responsibilities For Regulatory Affairs Associate Director Resume
- Good research skills and the drive and initiative to seek out ‘the right’ information; and
- Prior experience supporting direct sales and marketing organizations, preferably in pharmaceutical or health areas
- Learn registration processes and procedures as well as how to effectively argue company positions without damaging relationships with regulators
- Regulatory Affairs experience including the medical device and/or pharmaceutical area; preferably orthopaedic experience
- Strong sense of planning and prioritization
- Proven experience working in the Australian regulatory space
- Well-developed technical regulatory skills
3
Responsibilities For Global Regulatory Affairs Associate Resume
- Effectively communicate with representatives from regulatory agencies to ensure product and facility compliance to regulations
- Related Experience : Maximum 3-6 years experience in similar position in different types of registrations, preferably in multinational organization
- RA experience, with recent experience of working with Medicines (preferably OTC) in a UK/Ireland Capacity
- Organization skills and high accuracy in documentation
- Demonstrated experience with TGA ARTG applications and maintenance of certificates
4
Responsibilities For Regulatory Affairs Associate for Operations Resume
- Professional negotiation skills
- Flexibility and the ability to work effectively with a range of different Global functional areas
- Proven experience in the medical devices industry
- Demonstrated experience in a Regulatory Affairs Associate position
- Prior pharmaceutical experience involving chemistry and/or manufacturing
- Have exemplary oral and written communication skills
- Project organizational skills
- Substantial Experience in Regulatory Affairs and Clinical Research Experience in clinical study start-up
- Act with integrity and demonstrate a strong commitment to a quality mindset
5
Responsibilities For Clinical Regulatory Affairs Associate Resume
- Operate in a matrixed environment and manage multiple activities, priorities and deadlines
- Experience in the Pharmaceutical Industry, ideally within Regulatory Affairs, but experience in R&D, Quality or Operations also taken into consideration
- Communicating registration needs prior to and during product development
- Experience working within the renewables energy industry or working with executive and legislative branches of State/Federal government
- Experience writing technical reports Computer literacy including sound knowledge of the MS Office suite of software
- Demonstrates a sense of urgency around meeting commitments and timelines
- Consistently exercises good judgment in the application of policies and regulations. Works well with other individuals and departments in solving problems
- Execute plans, complete tasks according to priorities set by Manager, align work with business goals, and align actions with agreed strategies
- Experience working within CMC environment
6
Responsibilities For Principal Regulatory Affairs Associate for Medical Devices Resume
- Experience working in a virtual team and/or global organization would be an asset
- Experience working with limited supervision and able to make independent decisions is of advantage
- Experience working within the regulatory environment
- Experience in direct supervisions of personnel and managing remote teams; ability to lead and influence others
- Experience in supporting CMC submissions
7
Responsibilities For Regional Regulatory Affairs Associate Resume
- Knowledge of current Good Manufacturing Practices (cGMP) and establishment registration requirements
- Significant regulatory experience covering medical devices and/or pharmaceuticals
- Computer proficiency, including strong capabilities with PowerPoint
- Experience following Device Design Controls and Risk Management Processes
- MDR and Vigilance reporting, eMDR and UDI experience
- Experience working within a quality system such as ISO 9001, ISO 13485, FDA cGMP
- Previous experience interpreting industry and global EHSR standards
- Previous experience writing technical reports
- Regional regulatory experience including knowledge of CTA’s and NDA submission processes and product life cycle management activities
8
Responsibilities For Regulatory Affairs Associate Support Resume
- Experience with the SEBP and NMC meeting
- Excellent working knowledge of pharmaceutical regulations
- Pharmaceutical industry experience, specifically in Regulatory Affairs with a focus on Gx labeling
- Previous experience with imaging or medical device industry or clinical lab is desirable
- Previous experience preparing regulatory submissions
9
Responsibilities For Post-market Regulatory Affairs Associate Resume
- Previous experience representing function in a team environment
- Experience in working with a regulatory authority such as but not limited to the TGA
- Experience of working at a similar level within the pharma industry
- Experience of eCTD software for regulatory writing
- Experience working in Liquent’s InSight suite of tools desired
- Experience and subject matter expertise in regulatory affairs within the pharmaceutical industry preferably in the area of prescription medicines
- Maintain good working knowledge of relevant regulatory guidelines and procedures
- Demonstrated knowledge of all aspects of OTC medicine and/ or medical device regulatory compliance and regulations
- Demonstrated initiative and accountability in previous roles
10
Responsibilities For Regulatory Affairs Associate / Project Leader Resume
- Related professional experience in the pharmaceutical / biotechnology pharmaceutical or medical device industry for India registration
- Good proficiency for Microsoft Office (Word, Excel, PowerPoint)
- Experience with Class I and II device inclusions, desirable, but not essential
- Demonstrated ability to handle multiple projects is required
- Experience interacting directly with FDA and Notified Body reviewers/inspectors
- Needs to have good communication and organization skils
- Development of good working relationships with health authorities to support optimal business outcomes
- Regulatory and labeling experience with drugs, biologics, and devices
- Experience with electronic publishing tools (eCTDs) and electronic document management systems
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