Manager Regulatory Affairs
Sanofi
5 hours ago
Remote friendly (Morristown, NJ)
United States
Corporate Functions
Manager Regulatory Affairs
Main Responsibilities:
- Conduct independent review of advertising, promotional, communications, and other materials.
- Help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product launches.
- Contribute as product A&P expert to regulatory strategies for labeling, product defense, and development projects.
- Serve as primary liaison with FDA for advertising and promotional compliance matters (assigned products).
- Identify product-specific/therapeutic area A&P issues and propose/implement solutions.
- Advise on risk/benefit of different strategies and support sound business decisions regarding regulatory matters.
- Oversee and implement regulatory strategic objectives and projects with minimal supervision.
- Serve as regulatory representative on brand teams and Review Committees for commercial and medical materials.
- Provide guidance/feedback to commercial and R&D to maximize promotion/advertising/reimbursement impact; support global domestic regulatory strategies via life cycle management.
- Provide A&P expertise for optimal labeling on new and supplemental new drug applications.
- Develop product-specific regulatory strategies to mitigate risk and provide risk/benefit analysis with brand team management.
- Perform other duties as assigned.
Qualifications:
- Bachelor’s degree in Life Sciences (accredited four-year college/university).
- 1–3 years of experience in pharmaceutical or medical device Regulatory Affairs.
- Successful track record with ideally 1–3 years relevant regulatory experience.
- Experience with cross-functional groups (e.g., Medical, Legal, Marketing).
- Experience in Advertising and Promotion in Regulatory (required).
Knowledge, Skills, and Abilities:
- Knowledge of complex medical and scientific subject matter.
- Ability to work effectively in cross-functional teams.
- Strong oral and writing communication skills.
- Understanding of the U.S. pharmaceutical marketplace; familiarity with medical terminology.
- Ability to analyze data from different sources, draw conclusions, and develop solutions.
- Develop collaborative relationships and internal networks; propose innovative solutions.
- Interpersonal skills to gain acceptance of ideas/plans.
- Unquestionable ethics and professional integrity.
- Ability to balance projects with day-to-day duties; establish priorities and timelines; multitask effectively.
- Honesty and accuracy in representing information and data.
Benefits (explicitly stated):
- Health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
Main Responsibilities:
- Conduct independent review of advertising, promotional, communications, and other materials.
- Help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product launches.
- Contribute as product A&P expert to regulatory strategies for labeling, product defense, and development projects.
- Serve as primary liaison with FDA for advertising and promotional compliance matters (assigned products).
- Identify product-specific/therapeutic area A&P issues and propose/implement solutions.
- Advise on risk/benefit of different strategies and support sound business decisions regarding regulatory matters.
- Oversee and implement regulatory strategic objectives and projects with minimal supervision.
- Serve as regulatory representative on brand teams and Review Committees for commercial and medical materials.
- Provide guidance/feedback to commercial and R&D to maximize promotion/advertising/reimbursement impact; support global domestic regulatory strategies via life cycle management.
- Provide A&P expertise for optimal labeling on new and supplemental new drug applications.
- Develop product-specific regulatory strategies to mitigate risk and provide risk/benefit analysis with brand team management.
- Perform other duties as assigned.
Qualifications:
- Bachelor’s degree in Life Sciences (accredited four-year college/university).
- 1–3 years of experience in pharmaceutical or medical device Regulatory Affairs.
- Successful track record with ideally 1–3 years relevant regulatory experience.
- Experience with cross-functional groups (e.g., Medical, Legal, Marketing).
- Experience in Advertising and Promotion in Regulatory (required).
Knowledge, Skills, and Abilities:
- Knowledge of complex medical and scientific subject matter.
- Ability to work effectively in cross-functional teams.
- Strong oral and writing communication skills.
- Understanding of the U.S. pharmaceutical marketplace; familiarity with medical terminology.
- Ability to analyze data from different sources, draw conclusions, and develop solutions.
- Develop collaborative relationships and internal networks; propose innovative solutions.
- Interpersonal skills to gain acceptance of ideas/plans.
- Unquestionable ethics and professional integrity.
- Ability to balance projects with day-to-day duties; establish priorities and timelines; multitask effectively.
- Honesty and accuracy in representing information and data.
Benefits (explicitly stated):
- Health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.