Associate Director, Commercial Regulatory Affairs

About the role

The role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply complex scientific and expert regulatory advice and risk assessment for the development of promotional campaigns and materials for an assigned product/therapeutic area in order to help ensure the Company's objectives are met.

Responsibilities

• Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, Public Affairs, Value Access and Payment, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic area
• Provides solution oriented and innovative advice to meet the Company’s objectives and goals
• Leads training for Commercial teams on sub part e, 2253 regulations and FDA regulations on advertising and promotion
• Maintains full regulatory compliance of all promotions with approved labeling and /or FDA guidances
• Ensures regulatory compliance with sub part e and 2253 regulations
• Engages with colleagues within the department to help support them in their roles and development
• Pursues and understands diverse perspectives inside and outside BMS to provide risk assessment and mitigation strategies
• Develops and maintains strong working relationships with internal customers, including Commercial, Medical, Public Affairs, Legal and Compliance
• Integrates compliance considerations into risk assessment by partnering with Legal/Compliance colleagues
• Provides advice and guidance as appropriate on the development of draft product labeling to ensure commercially viable US labeling upon which future promotion and advertising will be based
• Promotes process improvement and BMS guiding principles as needed
• Engages with colleagues within the department to help support them in their roles and development
• Directly manages individuals depending on assignment
• Proactively seeks opportunities to learn and develop leadership skills

Qualifications

• Bachelor's degree required; advanced degree preferred (MS, PhD, PharmD, JD)
• Minimum of 3-5 years Regulatory promotional review or related pharmaceutical experience (e.g., Medical promotional review)
• Experience providing risk assessment to interdisciplinary teams on promotional materials and activities for marketed products and strong interest in FDA advertising and promotion regulations including guidance(s)
• Proven aptitude to analyze and interpret efficacy and safety data
• Experience communicating and negotiating with OPDPO
• 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