Manager Regulatory Affairs
Sanofi
5 hours ago
Remote friendly (Cambridge, MA)
United States
Corporate Functions
Main Responsibilities
- Conduct independent review of advertising, promotional, communications, and other materials.
- Develop and implement regulatory strategies for promotion and advertising campaigns; serve as regulatory lead for product launches.
- As product A&P expert, contribute to regulatory strategies for labeling, product defense, and development projects.
- Serve as primary liaison with the FDA for assigned products on advertising and promotional compliance.
- Identify product-specific or therapeutic area A&P issues and propose/implement solutions.
- Identify strategies for addressing issues; advise risk/benefit and support sound business decisions regarding regulatory matters.
- Oversee successful implementation of regulatory strategic objectives and projects with minimal supervision.
- Participate as Regulatory representative on brand teams and Review Committees (RC) for commercial and medical materials.
- Provide guidance/feedback to internal teams to maximize competitive impact of product development and promotion/advertising/reimbursement; input to Global domestic regulatory strategies for in-line products through life cycle management.
- Contribute A&P expertise to optimal labeling for new and supplemental new drug applications.
- Provide product-specific regulatory strategies to mitigate risk; advise on risk/benefit to maximize value to stakeholders.
Qualifications
- Bachelor’s degree in Life Sciences from an accredited four-year college or university.
- 1–3 years experience in pharmaceutical or medical device Regulatory Affairs.
- Track record with ideally 1–3 years relevant regulatory experience.
- Experience working cross-functionally (e.g., Medical, Legal, Marketing).
- Experience in Advertising and Promotion in Regulatory (required).
Skills/Knowledge
- Knowledge of complex medical and scientific subject matter.
- Strong oral communication and writing skills.
- Understand the U.S. pharmaceutical marketplace; familiarity with medical terminology.
- Ability to analyze data from multiple sources to draw conclusions and determine next steps.
- Ability to work effectively in cross-functional teams; build collaborative relationships and internal networks.
- Innovative, ethical, and able to prioritize and manage timelines/workload.
Benefits
- High-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Conduct independent review of advertising, promotional, communications, and other materials.
- Develop and implement regulatory strategies for promotion and advertising campaigns; serve as regulatory lead for product launches.
- As product A&P expert, contribute to regulatory strategies for labeling, product defense, and development projects.
- Serve as primary liaison with the FDA for assigned products on advertising and promotional compliance.
- Identify product-specific or therapeutic area A&P issues and propose/implement solutions.
- Identify strategies for addressing issues; advise risk/benefit and support sound business decisions regarding regulatory matters.
- Oversee successful implementation of regulatory strategic objectives and projects with minimal supervision.
- Participate as Regulatory representative on brand teams and Review Committees (RC) for commercial and medical materials.
- Provide guidance/feedback to internal teams to maximize competitive impact of product development and promotion/advertising/reimbursement; input to Global domestic regulatory strategies for in-line products through life cycle management.
- Contribute A&P expertise to optimal labeling for new and supplemental new drug applications.
- Provide product-specific regulatory strategies to mitigate risk; advise on risk/benefit to maximize value to stakeholders.
Qualifications
- Bachelor’s degree in Life Sciences from an accredited four-year college or university.
- 1–3 years experience in pharmaceutical or medical device Regulatory Affairs.
- Track record with ideally 1–3 years relevant regulatory experience.
- Experience working cross-functionally (e.g., Medical, Legal, Marketing).
- Experience in Advertising and Promotion in Regulatory (required).
Skills/Knowledge
- Knowledge of complex medical and scientific subject matter.
- Strong oral communication and writing skills.
- Understand the U.S. pharmaceutical marketplace; familiarity with medical terminology.
- Ability to analyze data from multiple sources to draw conclusions and determine next steps.
- Ability to work effectively in cross-functional teams; build collaborative relationships and internal networks.
- Innovative, ethical, and able to prioritize and manage timelines/workload.
Benefits
- High-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.