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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory Affairs within the pharmaceutical or medical device industry, focusing on advertising and promotion strategies, risk assessment, and compliance with U.S. regulations. Capable of collaborating with cross-functional teams to enhance product development and lifecycle management.
Highest-signal resume keywords
Regulatory Affairs ExperienceAdvertising And Promotion ExpertiseCross-Functional CollaborationData Analysis And Solution DevelopmentProject Management
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 Strategy DevelopmentRisk MitigationLabeling DevelopmentData AnalysisMedical Terminology Knowledge
Soft Skills
Solid Oral CommunicationWriting SkillsEthics And Professional Integrity
Industry Keywords
Pharmaceutical MarketplaceTherapeutic-Area AdvertisingRegulatory IssuesProduct DevelopmentLife-Cycle Management
About the role
Key responsibilities & impact- Identify product-specific or therapeutic-area advertising and promotion issues
- Propose and implement solutions to regulatory issues
- Evaluate strategies and advise clients on regulatory risks and benefits
- Oversee implementation of regulatory strategic objectives and projects with minimal supervision
- Participate as Regulatory representative on brand teams and Review Committees for commercial and medical materials
- Provide guidance to commercial and R&D groups to maximize product development, promotion, advertising, and reimbursement impact
- Provide input to Global organization on domestic regulatory strategies for in-line products through life-cycle management programs
- Contribute advertising and promotion expertise to labeling development for new and supplemental new drug applications
- Develop product-specific regulatory strategies to mitigate risk
- Partner with brand team management on advice and risk/benefit analysis
- Perform other duties as assigned
Requirements
What you’ll need- Bachelor’s degree from an accredited four-year college or university; science focus preferred but not required
- 1+ years of experience within pharmaceutical or medical device Regulatory Affairs
- Ideally 1–3 years of relevant regulatory experience
- Experience in Advertising and Promotion in Regulatory required
- Experience working effectively with cross-functional groups, including Medical, Legal, and Marketing
- Knowledge and understanding of complex medical and scientific subject matter
- Understanding of the U.S. pharmaceutical marketplace
- Familiarity with medical terminology
- Solid oral communication and writing skills
- Ability to analyze data from different sources, draw conclusions, and develop appropriate solutions
- Ability to establish priorities and timelines and manage multiple projects
- Ethics, professional integrity, and values consistent with Sanofi values
Benefits
Comp & perks- Supportive, future-focused team
- Opportunities for promotion or lateral career moves, at home or internationally
- Rewards package recognizing contribution and impact
- High-quality healthcare
- Prevention and wellness programs
- At least 14 weeks’ gender-neutral parental leave
- Employee benefit programs
- AI, data, and digital platforms at the forefront of drug discovery