Regulatory Scientist Resume Sample
Lola Harvey
877 Herman Plain,
Detroit,
MI
+1 (555) 287 8858
Work Experience
Senior Regulatory Scientist, G&C
07/2016
-
PRESENT
Los Angeles, CA
- Demonstrate knowledge from FDA meetings and regulatory trends to define the regulatory strategy and associated submission strategy
- Provide regulatory expertise to identify, prevent, and solve complex regulatory issues for product development
- Understand and communicate the benefits and risks of the product and ensures addressed in risk assessments
- Translate business unit needs / patient needs into product requirements and defined specifications
- Communicate and negotiate effectively with FDA and internal customers to ensure clear understanding and expectations of the strategy
- Provide high quality, timely, and critical regulatory advice to ensure well-informed decisions are made on new product development or lifecycle planning
- Work effectively with internal and external organizations to assess regulations for potential new products and influence the development work to meet regulatory expectations
- Negotiate and influences regulators such as FDA (CDRH, OCP, etc)
- Build, maintain, and leverage relationships with customers (particularly with FDA), team members, and partner companies as appropriate
Regulatory Scientist
08/2011
-
03/2016
Dallas, TX
- To perform literature searches in toxicology, chemical, environmental, and biological sciences to support generation of product safety reviews, setting appropriate substance classifications and registering DuPont products globally
- To manage internal document repository database
- Promoting Exponent’s services, particularly in the fields of REACH and new chemical notifications
- Proven experience of working in a regulatory environment
- Forward looking and creative and strategic thinker
- Staff management would be a distinct advantage
- Assessing our client’s obligations under the REACH legislation and development of appropriate regulatory strategies to enable them to meet these requirements
- Proven experience of working in a regulatory environment including hands on experience in the production of REACH regulatory dossiers and risk assessments
- Experience of staff management would be a distinct advantage
Regulatory Scientist Intern
03/2005
-
05/2011
Los Angeles, CA
- Project management, oral & written communication skills, organization and multi-tasking skills are required
- Propose regulatory strategies considering regulatory requirements, classification of changes, scheduling and priority setting
- Under supervision of the Team Lead / TA Lead ensure all regulatory activities are in alignment with the strategic direction of the GRAST
- Contribute to a GRA Strategy Document for complex projects and provide review of regional regulatory strategies
- Participate in GRASTs, as applicable
- To support toxicology testing and research functions in DuPont and contract laboratories by responding to information requests using various information science tools and techniques
- To summarize toxicology data (clearly and concisely), reports to overall summary for regional PS reviews and regulatory documents
Education
Texas A&M University
2000 - 2004
Bachelor's Degree in Food Science
Professional Skills
- Strong verbal and written communication skills to effectively communicate with internal and external customers and stakeholders
- Demonstrated effective oral and written communications skills, including effective customer interactions
- Strong problem solving and analytical skills supported by good attention to detail
- Demonstrated ability to set priorities effectively and manage multiple assignments
- Project management, organization and multi-tasking skills are required
- Proven learning agility, strong level of curiosity and willingness to learn
- Preferably 2-3 years’ pharmaceutical industry experience. Regulatory (including CMC regulatory) experience is highly desirable
How to write Regulatory Scientist Resume
Regulatory Scientist role is responsible for organization, oncology, training, database, wireless, reporting, manufacturing, design, research, assembly.
To write great resume for regulatory scientist job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Regulatory Scientist Resume
The section contact information is important in your regulatory scientist 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 Scientist Resume
The section work experience is an essential part of your regulatory scientist 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 scientist 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 scientist position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Regulatory Scientist resume experience can include:
- Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner
- Tracking project status and effectively communicating progress
- Effectively communicate in both spoken and written form
- Managing transition requests: preparation of the consolidated regulatory assessment
- Work on multiple projects (i.e., multi-task), organize, and prioritize within time constraints
- Pharmaceutical experience with knowledge of assigned regional regulatory procedures and legislation
Education on a Regulatory Scientist Resume
Make sure to make education a priority on your regulatory scientist resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your regulatory scientist 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 Scientist Resume
When listing skills on your regulatory scientist 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 scientist skills:
- RA CMC Global experience and heavy emphasis on experience authoring Module 3 CMC sections for major Global filings required
- Experience in software &/or computer systems design standards and verification and validation
- Knowledge of Good Clinical Practices (GCP) regulations and/or experience with clinical trial applications, IRBs, protocols, execution, and/or report summaries
- Demonstrable experience of effective delivery of objectives in a complex matrix environment
- Flexibility and the ability to work effectively with a range of different functional areas
- Demonstrates knowledge of global CMC regulatory requirements and guidelines for conducting Phase 1 and Phase 2 clinical trials
List of Typical Experience For a Regulatory Scientist Resume
1
Experience For CMC Regulatory Scientist Resume
- Strong experience in CMC requirements for small molecule/biologic products
- Labelling coordinator role for European brands
- Maintain and update established electronic system for indexing and retrieval of toxicology testing information using conceptual analysis techniques
- Develops CMC strategy for and filing of post approval changes and responding to agency or subsidiary questions
- Build contacts and understanding across the business, identifying business opportunities for Regulatory Affairs
- Serve as a team member in searching, GHS, and global registration processes
- Serve as a regulatory compliance subject matter expert for Stepan’s biocide business
- Contribute to the submission and maintenance of Stepan’s pesticide registrations at the state and federal level. under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and related regulations
- Monitor federal regulations related to Stepan’s pesticide products
2
Experience For Senior Regulatory Scientist, G&C Resume
- Implement compliance-related activities on Stepan’s behalf with state and federal agencies; customers and internal compliance efforts
- Act as a Regulatory Liaison to Stepan’s Business and Sales Divisions
- Preparing and updating CMC sections of IND/CTA for global submission of biological products; executing regulatory pre-approval filing strategies and variations for global products while ensuring that all regulatory documents are prepared accurately, completely and on-time; tracking project status and effectively communicating progress
- Lead the planning, preparation and delivery of both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective
- Provide regulatory and scientific support to the Regulatory staff and other internal business partners to support existing product lines, changes, and innovation projects in support of the company’s strategic initiatives. Work closely, particularly with R&D, to ensure product compliance in development
- Monitor and stay current on emerging issues related to food packaging safety, chemistry, toxicological information, and regulations for food, pet, and medical packaging. Complete analyses on the potential impact of these areas to Printpack’s business and communicate and collaborate internally on these topics
- Participate in maintaining and development of Printpack’s regulatory policies, guidelines, and procedures. Assist with design, implementation, and monitoring of systems and programs to ensure food safety and regulatory compliance of Printpack’s products based on scientific methodology
3
Experience For Lead Regulatory Scientist Resume
- Maintain product information systems for Technical Data System (TDS), Nutrition program, labeling programs, percentage range program, Allergen program, Kosher Certificate program, customer specification program and any product related research programs
- Manage and enter product data into the MAPICS databases for finished product and raw materials
- Process customer requests for product documentation
- Assist in the development of customer and product related information
- Secure confidentiality agreements with customers and prepare formula disclosures
- Understand regulations and impact on projects
- Collaborate and interact effectively with other Cook companies and global functions (e.g., Clinical, Quality, Marketing) within Cook to develop and implement a scientifically sound regulatory strategy for a project team
4
Experience For Manager, Regulatory Scientist, Oncology Resume
- Travel, as necessary, to support projects
- Familiarity with applicable regulatory requirements and regulatory submissions (including IDEs, PMAs, 510(k)s, Clinical Evaluation Reports, and other global regulatory documents) is beneficial
- Familiarity with statistical methods, analysis, and interpretation
- Commit to participate in a team-based environment
- Liaise with LOCs, and ensure responses to queries are made in a in timely manner, and that content is consistent with the regulatory strategy
- Responsible for multiple project assignments with critical timelines
- Designs the overall strategy for assigned projects
- Draws conclusions and makes strategy/process improvement recommendations
- Organizes and executes the overall regulatory project workload
5
Experience For Regulatory Scientist Intern Resume
- Manages regulatory databases and records to ensure proper tracking and metric reporting to internal stakeholders, business and upper management. Recommends system and tool upgrades
- Use available resources & databases to regularly review technical information, literature and regulations pertinent to fields of expertise
- Present technical information (regulatory strategies/knowledge) to customers to enhance relationships, Stepan image and increase sales
- Contributes to and actively participates in safety/waste programs and steadfastly adheres to safety policies, procedures and standards
- Communicates project results (internally to supervisor, project leader, requester, agencies)
- Order/communicate supply and information needs
- Judiciously spend Agency submission fees
- Build and expands the technical toolbox: new regulatory and registration strategies
- Participate in regulatory reviews with external customers and authorities
6
Experience For Regulatory Scientist Cimzia Resume
- MS or BS in Chemistry or related science/regulatory
- Review requisite critical data for completeness and suitability for submission to regulatory authorities domestic and abroad as required
- Maintain knowledge of federal, state and local regulatory requirements applicable to pre-market submissions for medical devices
- Assess new technologies for regulatory pathways
- Collaborate with Vice President of Regulatory Scientific Affairs to achieve appropriate review, technical accuracy and submission quality as necessary
- Preparing and updating CMC sections and ancillary GMP documentation for of global Marketing Authorizations; executing regulatory filing strategies while ensuring that all regulatory documents are prepared accurately, completely and on-time; tracking project status and effectively communicating progress
- Proficiency needed in MS Office programs (Word, Excel, Outlook).
7
Experience For Senior Regulatory Scientist Resume
- Reporting to the Director, the Associate Director is responsible for developing and implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations and guidance, and company procedures
- Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle
- Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks
- Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, and responses to health authority questions per established business processes and systems
- Collaborate with MMD and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance
- Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity
- Assess and communicate potential regulatory risks and propose mitigation strategies
- Identify, communicate and escalate potential regulatory issues to GRACS CMC management, as needed /
- Lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines
8
Experience For Senior Reach Regulatory Scientist Resume
- At least seven (7) years of relevant experience, including research; manufacturing, testing, or licensure of pharmaceutical, vaccine, or biological products; or related fields
- Provide input to project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks
- Liaise with MMD and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance
- Identify and communicate potential regulatory issues to GRACS CMC, as needed
- Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data
9
Experience For R&D Regulatory Scientist Resume
- Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance)
- Capability to handle multiple priorities and balance work to achieve business goals
- At least five (5) years of relevant experience, including research; manufacturing, testing, or licensure of pharmaceutical, vaccine, or biological products; or related fields
- Individual Contributor within GRACS-CMC responsible for the preparation of chemical and pharmaceutical manufacturing and control (CMC) content and maintenance of CMC documentation for worldwide registration
- Develops CMC strategy for and filing of post approval changes and responding to agency or subsidiary questions. Maintain working knowledge of current governmental and worldwide requirements for and filing of post approval changes and responding to agency or subsidiary questions
- Conduct searching using various information science tools and techniques
- Maintain working knowledge of current governmental and worldwide requirements for
- Produce Product Stewardship and Regulatory deliverables
10
Experience For Reach Regulatory Scientist Resume
- Maintain proficiency in current search strategies and resources
- Review search results to determine potential key information
- Analyze and summarize key information into appropriate deliverable format
- Adapt content and format of the deliverable in response to request from the toxicologists
- Serve as team member for GHS classifications, Registration submissions, and/or Product Stewardship Documents
- Serve as a team member for processes on multi-disciplinary teams within the company
List of Typical Skills For a Regulatory Scientist Resume
1
Skills For CMC Regulatory Scientist Resume
- Proven organizational skills and excellent written/verbal communication are required
- Write, and/or coordinate the preparation of clear and effective documents, including submissions to global regulatory authorities
- Pharmaceutical experience with knowledge of Americas regional regulatory procedures and legislation
- Relevant science experience
- Designing & developing consumer medical devices / home health solutions, including Human Factors requirements and testing
- Preparing and updating CMC sections and ancillary GMP documentation for of global Marketing Authorizations
- Executing regulatory filing strategies while ensuring that all regulatory documents are prepared accurately, completely and on-time
- Building technical knowledge, expertise and vision in regulatory, registration and compliance strategies as well as monitoring methods
2
Skills For Senior Regulatory Scientist, G&C Resume
- Understanding of the drug development process is required
- Understanding of the regulatory submission and approval process is required
- Labelling coordinator role for a EU brand
- Building subject matter expertise in advocacy, regulatory & registration processes and strategies
- Planning and project management of large, complex activities
- Assist in contributing to the regulatory affairs assessment and due diligence of new in-licencing opportunities, including regulatory risk assessments
3
Skills For Lead Regulatory Scientist Resume
- Contribute to efficiency and process improvement including development of best practices, SOP maintenance and appropriate tracking tools, templates
- Assist in the review of change requests for adequacy of supporting data and to determine necessity of reporting to regulatory authorities
- Support Global Regulatory Strategy Team (GRAST) members for the strategy, planning and preparation of regulatory documents
- Application of risk assessments, analysis, building FMEAs, FTA, and Safety Assurance Cases
- Complex problem solving, team lead/facilitator, knowledge of Global regulations related to CMC, superior written/oral communication, fluent in English language
- Provide direction and leadership from a technical and regulatory point of view to a project team pursuing approval of a new product
- Independently manages projects and assignments following established Stepan project management procedures and project plans
- Keep documentation (e.g. project tracking, compliance records and reports)
- Helps grow product sales and profit by implementing creative regulatory strategies
4
Skills For Manager, Regulatory Scientist, Oncology Resume
- Provide technical advice and training to colleagues (e.g., regulatory strategies and knowledge)
- Assists with training of customers & advocacy with regulatory authorities and industry consortia
- Provide chemistry expertise, and work with internal and external partners to guide testing and chemical analysis of components
- Develop and implement testing and regulatory strategies for new medical devices
- Coordinate with product development, non-clinical and contract research organizations as needed for meeting project completion target dates
5
Skills For Regulatory Scientist Intern Resume
- Provide leadership/mentoring for Associates and Specialists
- Individual Contributor within GRACS-CMC responsible for the preparation of chemical and pharmaceutical manufacturing and control (CMC) content and maintenance
- Deep technical knowledge of CMC drug development science(s)
- Assist in the development of regulatory strategy and update strategy based upon global regulatory changes
- Provide high quality, timely and decisive regulatory advice to allow CMC Teams to make well-informed decisions on early phase development
6
Skills For Regulatory Scientist Cimzia Resume
- Evaluate regulatory impact on proposed CMC development plans
- Anticipates and resolves key technical or operational issues that have the ability to impact the function or CMC team
- Participates in risk-benefit analysis for regulatory compliance
- Ensure that dossiers meet the content and format requirements for relevant regulatory authorities via effective communication with the Team Lead/TA Lead, Regional Regulatory Affairs Manager/Local Regulatory Affairs Manager (RRM/LRM), GRLs and other GRAST members
- Experience with business development in the government, biotechnology, pharmaceutical, or life science sector
7
Skills For Senior Regulatory Scientist Resume
- Coordinate the development of responses to HAs for the respective GRA Function, as applicable
- Identify risks and issues and to alert managers as appropriate
- A timely and thorough manner
- Knowledge of the regulatory environment, US guidelines and practices is required
- Bachelors Science or Engineering with 7-10 years of increasing responsibility in medical device product development, 3-5 years of which include experience in development of software as or in medical devices
- With FDA interactions &/or submissions
- Extensive experience with preparing strategies and conducting FDA interactions and successfully securing a number of FDA clearances and/or approvals (510(k), IDE, PMA)
- Knowledge and experience with connected medical devices. Experience with firmware & software development, system controls, cybersecurity, wireless and/or handheld device application development and familiarly with engineering technologies, and requirements
8
Skills For Senior Reach Regulatory Scientist Resume
- Knowledge &/or experience of Regulatory roles with responsibility with software as or in medical device products
- Demonstrated ability to organize key messages and connect rationale that supports or highlight risks of gaps in written, spoken, and presentation communication skills
- Demonstrated ability to understand information indexing and retrieval concepts
- Good working knowledge of regulatory affairs legislation and guidelines for Australia and New Zealand
- Regulatory experience in a biotech or plasma protein company is an advantage
- Demonstrated knowledge of global regulatory requirements and ability to summarize and communicate information as appropriate
9
Skills For R&D Regulatory Scientist Resume
- Demonstrated proficiency of Excel, Word, PowerPoint, and Microsoft Access
- Demonstrated ability to consistently function as a team player
- Build strong, credible relationships with licensors/partners and assessors in the TGA and Medsafe
- Demonstrate leadership and ability to think beyond immediate responsibilities and apply knowledge to new situations
- Identify the ‘big picture’ and opportunities/major issues and link day to day tasks with long term goals
- Familiarity with UN GHS Purple Book regulations
- Familiarity with toxicology terminology, acronyms, and the concepts of routes of exposure, clinical signs, target organs effects, lethal doses, and exposure limits
- Familiarity with Safety Data sheet section content and health & safety phrases
- Knowledge and experience searching databases like TOXLINE®, the Hazardous Substances Data Bank, the Integrated Risk Information System, the Toxic Release Inventory, Chemical Abstracts, Medline, ChemIDplus, NTIS, etc
10
Skills For Reach Regulatory Scientist Resume
- Demonstrated knowledge of SAP-EHS or other SDS creation software
- Experience in the food industry, or associated industries (pharmaceutical, consumer products, nutritional supplements, etc.) primarily in product safety regulatory affairs, regulatory compliance
- Strong customer focus for internal and external customers
- Work autonomously as well as part of a cross function team
- Critically appraise data
- Proficiency for Microsoft Office (Word, Excel, PowerPoint)
- Committed and team oriented
List of Typical Responsibilities For a Regulatory Scientist Resume
1
Responsibilities For CMC Regulatory Scientist Resume
- Working experience in Regulatory Affairs or a Quality function
- In depth knowledge of and experience in regulatory tools and processes
- Know the brand strategies, ensuring timely communication of regulatory activities and timelines to support brand planning
- Maintain working knowledge of current governmental and worldwide requirements
- Maintain databases for various processes (Database 3, IUCLID, SAP-EHS)
- Monitor current requirements to ensure regulatory compliance – raise to awareness of toxicologists
- Serve as Database Manager for Internal Document Repository System
- Maintain working knowledge of current governmental and worldwide requirements for and filing of post approval changes and responding to agency or subsidiary questions
2
Responsibilities For Senior Regulatory Scientist, G&C Resume
- Raw material, recipe and finished product review and approval
- Ingredient and nutritional claim validation and validation of more complex claims; including claims on pack, in advertisements and other media for European (including local) brands under its scope
- Products Labelling Reports (PLRs) generation for European (including local) brands
- Interact and communicate as a regulatory partner with multiple functions including RD&Q, Product change management, Marketing, Consumer services, Supply chain, Legal, Corporate affairs, and country management
- Profound knowledge of European Food Legislation
- Contribute to the development and implementation of the regional regulatory strategy for products in-licensed by Seqirus
3
Responsibilities For Lead Regulatory Scientist Resume
- Assist in the planning, preparation, review and submission of high quality applications in Australia/New Zealand (and other territories as applicable) including Category 1/3 applications, responses to questions, and regulatory agency briefing documentation
- Maintain awareness and inform Manager of risks to assist with communication to Health Economics, Marketing and Business Development colleagues at all stages of the in-licencing process
- Assist in the development of creative problem solving strategies to address perceived deficiencies in dossiers from in-licensing partners to optimise the best outcomes to achieve a successful registration and/or commercially competitive prescribing information
- In collaboration with In-Licencing partners and Global Strategic Labelling assist in the maintenance of up to date product labelling (PI, CMI, etc.) for in-licensed products
- Communicate across all levels, teamwork, IT skills
- Represent UK Regulatory Affairs (DRA) both externally, internally at EU/HQ level, and in cross-functional teams to support the business
- Lead in interactions with national regulatory agencies on policy, scientific advice and product issues
4
Responsibilities For Manager, Regulatory Scientist, Oncology Resume
- Give strategic and relevant regulatory input to support development and lifecycle management
- Seek knowledge in specialist areas, interpret and communicate impact analysis within Regulatory Affairs and across relevant business areas
- Assess content of proposed national submissions, proposing solutions to correct deficiencies and ensuring high quality regulatory submissions are made and implemented in a timely manner in collaboration with colleagues to maintain compliance
- Ensure questions and commitments from our national regulatory authorities are proactively managed
- Support the department in preparations for Brexit
- Plan and manage a variety of long term projects, control activities and meet deadlines
5
Responsibilities For Regulatory Scientist Intern Resume
- Prepare and deliver regulatory operational plans for assigned projects/products within a specific region
- Provide strategic and operational regulatory input and guidance in cross-functional team
- Manage quality regulatory submissions to agreed project targets
- Work flexibilty within and across regions to provide broad operational support to ensure the delivery of product team and business objectives
- Successful track record in Regulatory Affairs, including stakeholder management and experience of UK or EU management of Marketing Authorisations and CTAs. Experience in other aligned areas e.g. drug safety, clinical trials, discovery or development research desirable
- Relevant pharmaceutical industry
- Reporting to the Associate Director, the Sr. Specialist is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance and defined regulatory strategies. The Senior Specialist is responsible for the preparation and review of information required for development of regulatory CMC dossiers for commercial products
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