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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in US regulatory strategies and interactions with health authorities, particularly the FDA, while effectively managing regulatory submissions and cross-functional collaborations. Possesses strong analytical skills to assess regulatory risks and guide stakeholders through complex development processes.
Highest-signal resume keywords
Regulatory Affairs ExperienceFDA InteractionRegulatory Strategy DevelopmentBiotechnology Industry KnowledgeCross-Functional Team Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Submission PreparationModule 1 DocumentationRegulatory Risk AssessmentPediatric Plans DevelopmentCore Document PreparationRegulatory Pathways KnowledgeHealth Authority NegotiationRegulatory IntelligenceSubmission Materials DevelopmentRegulatory Deliverables Management
Soft Skills
Judgment and Decision-MakingRelationship BuildingCommunication SkillsAccountability PromotionCollaboration
Certifications & Qualifications
Bachelor’s Degree in Life ScienceAdvanced Degree Preferred
Industry Keywords
BiotechnologyPharmaceutical IndustryRegulatory RequirementsDevelopmental ProductsHealth AuthorityUS Regulatory StrategiesGlobal Regulatory TeamsCross-Functional TeamsMatrixed Reporting StructuresProduct Lifecycle
About the role
Key responsibilities & impact- Contribute US regulatory expertise to integrated global regulatory strategies for assigned products
- Develop and maintain relationships with the FDA and support or lead health authority interactions and negotiations
- Lead or contribute to regional regulatory activities for investigational, new, and marketed products
- Prepare submission materials, core documents, briefing books, pediatric plans, and other regulatory deliverables
- Oversee preparation and coordination of required Module 1 documentation for US regulatory submissions
- Support responses to health authority questions and comments
- Partner with Global Regulatory Leads, Regulatory Affairs teams, Regulatory CMC, commercial operations, and other stakeholders
- Provide guidance on FDA requirements, regulatory pathways, filing categories, processes, and ways of working
- Assess regulatory risks, identify opportunities, and advise stakeholders on development and approval challenges
- Contribute to regulatory strategy development, document reviews, and competitive regulatory intelligence
- Drive timely completion of regional regulatory deliverables and promote accountability across project teams
- Communicate global regulatory strategies and decisions to regional commercial stakeholders
- Build working relationships across global and regional regulatory teams throughout the product lifecycle
Requirements
What you’ll need- Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, or a related life science field required
- Minimum of seven years of experience in the biotechnology or pharmaceutical industry
- At least five years of regulatory affairs experience
- At least three years of experience supporting regulatory activities for developmental products
- Experience working in Regulatory Affairs with responsibility for interaction with at least one health authority
- Developing knowledge of pharmaceutical or biological product development and regulatory requirements for development and approval in a major region, such as the US, EU, or Japan
- Experience working within cross-functional teams and matrixed reporting structures
- Ability to evaluate options, exercise sound judgment, and make informed decisions in complex situations
- Advanced degree in a related discipline, such as an MS, PhD, MD, DVM, or MBA, preferred
Benefits
Comp & perks- Incentive compensation may be included in total compensation
- Equity may be included in total compensation
- Reasonable accommodation available for individuals with disabilities during the application process