Associate Director Commercial Regulatory Affairs

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Associate Director Commercial Regulatory Affairs
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 Office Of Prescription Drug Promotion advisory submissions and sub part e submissions. Ensure full regulatory compliance of all promotions with approved labeling and /or FDA guidances. Ensure regulatory compliance with sub part e and 2253 regulations. Lead training for Commercial teams on sub part e, 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.

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