Associate Director, Commercial Regulatory Affairs

The Associate Director of US Commercial Regulatory Affairs will apply complex scientific and expert regulatory advice and risk assessment for the development of promotional campaigns and materials for an assigned product/therapeutic area. The role requires ensuring materials are consistent with BMS guiding principles, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidances.

What You Will Do

Provides regulatory advice, risk assessment, and mitigation strategies to Commercial Teams, Medical Affairs, Public Affairs, Value Access and Payment, and other internal groups. Develops and maintains strong working relationships with internal customers, including Commercial, Medical, Public Affairs, Legal, and Compliance.

Why It Might Be a Fit

The ideal candidate will have a strong interest in FDA advertising and promotion regulations, including guidance(s). They will be able to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaigns. Excellent verbal, communication, and presentation skills are required.

Requirements

• BS required; advanced degree preferred (MS, PhD, PharmD, JD)
• Minimum of 3-5 years Regulatory promotional review or related 5 to 8 years pharmaceutical experience
• Experience providing risk assessment to interdisciplinary teams on promotional materials and activities for marketed products
• Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaigns
• Proven aptitude to analyze and interpret efficacy and safety data
• Experience communicating and negotiating with OPDP
• Organizational skills and ability to pay attention to details
• Demonstrated ability to negotiate and influence others to help build team collaboration
• Excellent verbal, communication, and presentation skills
• Excellent interpersonal skills, flexibility, adaptable to a changing environment and adeptness to communicate effectively with cross-functional teams and with business partners across the company

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP)
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support
• Paid Time Off
• Flexible time off (unlimited, with manager approval)
• 11 paid national holidays
• 160 hours annual paid vacation for new hires with manager approval
• 11 national holidays, and 3 optional holidays
• Unlimited paid sick time
• Up to 2 paid volunteer days per year
• Summer hours flexibility
• Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
• Annual Global Shutdown between Christmas and New Years Day