Associate Director, US Commercial Regulatory Affairs – Advertising and Promotion (Hybrid)

About the position 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. Individual will ensure materials are consistent with BMS guiding principles, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidances.

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
• Provide strategic advice for the development of Advertising and Promotional Labeling Branch (APLB) and Office Of Prescription Drug Promotion (OPDP) advisory submissions and subpart E and H submissions
• Ensure full regulatory compliance of all promotions with approved labeling and /or FDA guidances
• Ensure regulatory compliance with subpart E/H and 2253 regulations
• Lead training for Commercial teams on subpart E/H, 2253 regulations and FDA regulations on advertising and promotion
• Ensure monitoring and maintenance of knowledge of the evolving regulatory landscape to provide innovative solutions and advice
• Pursues and understands diverse perspectives inside and outside BMS to provide risk assessment and mitigation strategies
• Develop and maintain strong working relationships with internal customers, including Commercial, Medical, Public Affairs, Legal and Compliance
• Integrate compliance considerations into risk assessment by partnering with Legal/Compliance colleagues
• Provide 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
• Provide input on process improvement and BMS guiding principles as needed
• Engages with colleagues within the department to help support them in their roles and development
• Provide direct management to individuals depending on assignment
• Proactively seeks opportunities to learn and develop leadership skills

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 (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)
• 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/APLB
• 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

• Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
• Medical, pharmacy, dental and vision care.
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
• Financial well-being resources and a 401(K).
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
• Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
• Parental, caregiver, bereavement, and military leave.
• Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
• Other perks like tuition reimbursement and a recognition program.

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