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Director, Commercial Regulatory Affairs

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The Director, Commercial Regulatory Affairs provides strategic input into the review and approval of effective yet FDA compliant commercial (advertising and promotion) campaigns and pre-commercialization activities. This person will serve as the regulatory lead and on at least two Copy Review Committees (CRCs) which they will Chair, and on the respective Product Medical Review Committees (PMRC). The Director will lead the Commercial Regulatory Affairs function responsible for managing the advertising and promotion material review and approval process through all product CRCs and the FDA submission process for branded materials.

Responsibilities include but are not limited to:

1. As CRC Chair moderate purposeful discussions in a solution-orientated and time-sensitive manner, swiftly lead the committee to consensus on the approval of materials or the need to escalate, ensure that CRC members uphold the Company values during CRC meetings and other CRC-related activities, and foster close collaboration with the Business Owner to optimize the quality of the materials and accelerate their review and approval.

2. Ensure a highly effective and efficient review and approval process for advertising and promotion materials and the timely and accurate submission of branded materials to FDA in compliance with FDA regulations.

3. Lead the development of best practices and procedures for CRCs including the maintenance of the CRC SWP to ensure the consistency, accuracy and quality of the advertising and promotion review and approval process.

4. Ensure robust training program on the advertising and promotion review and approval process is implemented for all CRC stakeholders, as well as support training on the regulatory requirements for advertising and promotion review and approval and the regulatory landscape.

5. Review and approve all advertising and promotional materials, concept reviews and pre-commercialization materials for assigned products in collaboration with commercial, clinical and legal to ensure that they comply with FDA regulations. Provide strategic input into labeling as a member of core labeling development teams.

6. Act as liaison with OPDP for assigned marketed products to facilitate the FDA review of advertising and promotional materials (e.g. launch materials submitted for advisory).

7. Provide legal, clinical and commercial with updates on new FDA guidance, the issuance of enforcement letters by OPDP and other Company or competitor product FDA correspondence.

8. Develop, implement and maintain regulatory procedures regarding review of advertising and promotional materials for marketed products and pre-commercialization materials for products or uses prior to FDA-approval.

Minimum Bachelor's Degree or higher in life sciences
• 10 – 12 years in Regulatory, R&D or related area with at least 5 years of experience in commercial regulatory affairs or equivalent experience within the pharmaceutical industry.
• Strong leadership skills with demonstrated ability to lead teams and collaborate with key cross-functional stakeholders.
• In depth knowledge of FDA regulations and guidance documents regarding advertising/ promotion and labeling
• Demonstrate strong project management, problem solving, strategic thinking, decision making, conflict management, influence, negotiation, interpersonal and communication skills (both written and oral) attention to detail and ability to work under tight timelines.
• Minimal travel: less than 5% domestic travel to meetings and conferences

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