Associate Director, Commercial Regulatory Affairs – Parsippany

Job Summary: We currently have an opening for an Associate Director, Commercial Regulatory Affairs, in our Parsippany, New Jersey location. This position will be responsible for the management, review and approval of all advertising and promotional materials for assigned products as a member of the Daiichi Sankyo, Inc. (DSI) Advertising Review Committee(s), and will prepare all FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) submissions and serve as the liaison to DDMAC for all assigned DSI products marketed by the company (consumer and professional markets). The incumbent will serve as a member of the Programs and Grants Committee to review and approve all programs and items of value for distribution to HCPs.

Responsibilities: In this position you will provide regulatory review of proposed advertising and promotional materials submitted to DSI's Advertising and Review Committee (ARC) and review medical letters for assigned products prepared by Medical Affairs to ensure non-promotional tone and scientific balance. You will provide advice to the Legal Affairs Department relative to regulatory and promotional issues involving pharmaceutical products and/or medical devices and regulatory guidance and training on policies and procedures impacting commercial operations. You will maintain current in-depth knowledge of regulatory requirements, including but not limited to, the Code of Federal Regulations, the FDA, and the Federal Trade Commission, especially with regards to the advertising and promotion of pharmaceutical products. Additionally, you will collaborate with the Head of Commercial Regulatory Affairs for the preparation and submission of FDA 2253 filings for pharmaceutical products.

Education/Experience Requirements: Qualified candidates must have a Bachelor's degree (or higher) with appropriate regulatory experience OR a Master's degree. Concentration in a Life Science is preferred. JD degree and/or PharmD is preferred. You must have a minimum of 5 years of relevant pharmaceutical experience. Strong communication, presentation, organization, time management, leadership, influence and interpersonal skills are essential. Additionally, you must have demonstrated in-depth working knowledge of FDA guidelines/regulations, Code of Federal Regulations and Federal Trade Commission; work effectively in a team setting as well as possess strong collaborative skills. Prior positions held should demonstrate progressive experience with promotional and advertising materials.

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