Job title: Regulatory Affairs Director, Advertising & Promotion
Job description: Within Regulatory Affairs, Proclinical is working closely with its client to fill their position as Regulatory Affairs Director. This opportunity is hybrid with requirements to come into the office 1-2 times per week. The Director, Commercial Regulatory Affairs will have accountability for review of promotion and medical communications for assigned brands, their products first use submissions and reports on postmarked requirements made to FDA.
- Serve as the internal subject matter expert on FDA Advertising & Promotion issues and provide internal training as needed on FDA requirements
- Liaise with FDA/OPDP as needed for assigned products
- Lead the Promotional Review Committee (PRC) Process for assigned products providing guidance to maintain compliance with FDA advertising and promotional regulations, pertinent laws and company policy
- Foster a business partnership environment between Regulatory and PRC partner functions in the review and approval of this company advertising and promotional materials
- Collaborate with Global Regulatory Affairs to align strategy to US Commercial Teams’ strategic imperatives
- Develop SOPs and working instructions to facilitate consistent high performing commercial regulatory operations and efficient promotional review process
- Lead PRC teams in management of: re-review and expiry of approved materials and implementation of revised product labels in promotional materials, revised promotional content, safety information and requisite training materials for reps
Skills and Requirements:
- BS or MS in scientific discipline; advanced scientific degree preferred
- Advanced and/or bachelor’s degree in a scientific discipline with a minimum of 10 years of experience in the biotech/pharmaceutical industry and a minimum of 7 years in regulatory affairs
- Experience in Endocrinology, Neurology, and Oncology a plus
- Ability to understand and interpret clinical data. Expert understanding of FDA promotional regulations and reports on post marketing requirements
- Oversee OPDP submissions process and author all submissions for assigned products
Benefits and Perks:
- Salary is $210k – $230k; 25% Bonus; also potential for a signing on bonus; they will also match 401k at 12% if you put in 6%.
- Medical and prescription drug coverage
- Wellness Programs
- Dental Coverage
- Vision coverage
- Disability insurance
- Life and AD&D insurance
If you are having difficulty in applying or if you have any questions, please contact Lauren Banks at (+1) 929-244-2402 or [email protected]
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
Job date: Sat, 04 Jun 2022 03:09:02 GMT
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