Manager Regulatory Affairs
Sanofi
2 months ago
Remote friendly (Morristown, NJ)
United States
Corporate Functions
Main Responsibilities:
- Identify product-specific or therapeutic area A&P issues and work with other teams to propose and implement solutions.
- Identify strategies for addressing issues; advise on risk/benefit and support sound business decisions regarding intervening regulatory matters.
- Oversee and take responsibility for successful implementation of regulatory strategic objectives and projects with minimal supervision.
- Serve as Regulatory representative on brand teams and Review Committees (RC) for commercial and medical materials.
- Provide guidance and feedback to internal stakeholders (commercial groups, R&D) to maximize product development impact, and support promotion, advertising, and reimbursement; provide input to Global on domestic regulatory strategies for in-line products through life cycle management programs.
- Contribute A&P expertise to development of optimal labeling on new and supplemental new drug applications.
- Provide product-specific regulatory strategies to mitigate risk; partner with brand team management on advice and risk/benefit analysis to maximize value to stakeholders.
- Serve as primary liaison with FDA for assigned products on advertising and promotional compliance matters.
- Perform other duties as assigned.
Qualifications:
- Bachelor’s degree in Life Sciences from an accredited four-year college or university.
Required Work Experience:
- 1–3 years experience in pharmaceutical or medical device Regulatory Affairs.
- Successful track record with ideally 1–3 years relevant regulatory experience.
- Experience working effectively with cross-functional groups (e.g., Medical, Legal, Marketing).
Knowledge, Skills, and Abilities:
- Knowledge of complex medical and scientific subject matter.
- Ability to work well within cross-functional teams.
- Strong oral communication and writing skills.
- Understanding of the U.S. pharmaceutical marketplace; familiarity with medical terminology.
- Ability to draw conclusions from data from multiple sources and choose a course of action.
- Demonstrated collaboration, innovation, interpersonal skills, ethical integrity, priority/timeline management, and multitasking.
Benefits (if applicable):
- Wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Identify product-specific or therapeutic area A&P issues and work with other teams to propose and implement solutions.
- Identify strategies for addressing issues; advise on risk/benefit and support sound business decisions regarding intervening regulatory matters.
- Oversee and take responsibility for successful implementation of regulatory strategic objectives and projects with minimal supervision.
- Serve as Regulatory representative on brand teams and Review Committees (RC) for commercial and medical materials.
- Provide guidance and feedback to internal stakeholders (commercial groups, R&D) to maximize product development impact, and support promotion, advertising, and reimbursement; provide input to Global on domestic regulatory strategies for in-line products through life cycle management programs.
- Contribute A&P expertise to development of optimal labeling on new and supplemental new drug applications.
- Provide product-specific regulatory strategies to mitigate risk; partner with brand team management on advice and risk/benefit analysis to maximize value to stakeholders.
- Serve as primary liaison with FDA for assigned products on advertising and promotional compliance matters.
- Perform other duties as assigned.
Qualifications:
- Bachelor’s degree in Life Sciences from an accredited four-year college or university.
Required Work Experience:
- 1–3 years experience in pharmaceutical or medical device Regulatory Affairs.
- Successful track record with ideally 1–3 years relevant regulatory experience.
- Experience working effectively with cross-functional groups (e.g., Medical, Legal, Marketing).
Knowledge, Skills, and Abilities:
- Knowledge of complex medical and scientific subject matter.
- Ability to work well within cross-functional teams.
- Strong oral communication and writing skills.
- Understanding of the U.S. pharmaceutical marketplace; familiarity with medical terminology.
- Ability to draw conclusions from data from multiple sources and choose a course of action.
- Demonstrated collaboration, innovation, interpersonal skills, ethical integrity, priority/timeline management, and multitasking.
Benefits (if applicable):
- Wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.