Job Title: Director Regulatory Affairs Advertising & Promotion
Location: PA, NJ, NY
Brio Resource Group is a Life Sciences Executive Search Firm committed to providing rare talent on an exclusive search basis to the Biopharma, Pharma, Device and CRO industries. We work on behalf of organizations that value true talent acquisition partners and specialize in supporting emerging Biopharma companies offering life-changing therapies. Our many years of experience, subject matter expertise, comprehensive search process and genuine passion to deliver rare talent defines Brio.
As a Director of Regulatory Affairs (Advertising and Promotion), you will be responsible for offering strategic guidance and leadership in commercial regulations, ensuring compliance and meeting the commercial requirements of the US Business.
- Evaluate and authorize promotional, medical, payor, corporate, and other non-promotional materials to ensure compliance with relevant regulations, guidance documents, and internal policies/best practices
- Collaborate with Medical, Legal, Commercial, and Compliance teams to execute and approve significant Commercial campaigns, offering expert guidance to assess and mitigate potential risks
- Deliver presentations to senior management and cross-functional teams, sharing insights derived from FDA advisory comments, recent enforcement actions, and guidance documents
- Act as the primary regulatory contact between the company and the FDA’s Advertising and Promotional Labeling Branch and Office of Prescription Drug Promotion, ensure timely submission of materials to the FDA using form 2253
- Support the development of metrics to assess and monitor the effectiveness and efficiency of the promotional review process, provide recommendations for process improvements to address potential issues
Position Requirements: Bachelor’s Degree Required, in a Scientific Discipline
- 10+ years of experience in Regulatory Affairs or a related field, specifically in drug, biologic, and/or combination products
- 10+ years of experience in Regulatory Affairs promotion and advertising, working with prescription drugs, biologics, and/or combination products
- Experience managing significant regulatory filings with the FDA’s Office of Prescription Drug Promotion
- Stay up-to-date with relevant government regulations, particularly those pertaining to advertising and promotion
We welcome the opportunity to provide a full job description upon resume review.
How to Apply:
In order to be considered for the above opportunity, simply apply via LinkedIn and include your CV.
We respond to applicants who meet our position requirements, but suggest submitting your resume for future consideration for our expanding list of new opportunities surfacing daily within our Biopharma network. We have a strict honor code at Brio respecting your confidentiality and we only share your information with your consent.
Brio Resource Group, LLC considers all applicants without regard to race, color, religion, sex, national origin, age, mental or physical disabilities, or any other similarly protected status.