Director, Regulatory Affairs Advertising, Promotion, and Labeling
Our client is a science-driven biopharmaceutical company. They have asked us to assist them in their search for a Director, Regulatory Affairs Advertising, Promotion, and Labeling
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Serves as regulatory expert and provides guidance for all promotional materials within a collaborative cross-functional team.
- Chairs Promotional Review Committee and staff supporting the committee.
- Oversees Scientific Review Committee responsible for review of medical information materials, materials used by MSLs during HCP interactions, HEOR materials and other medical presentations.
- Serves as primary point of contact with the FDA Office of Prescription Drug Promotion (OPDP) for assigned products.
- Reviews and approves Form FDA-2253 submissions to OPDP.
- Collaborates cross-functionally to develop and implement revised/new labeling.
- Supports documentation for assigned products.
- Interprets scientific and clinical data.
- Manages the development of labeling to enhance product potential and patient benefit-risk ratio.
- Maintains awareness of regulatory legislation pertaining to both promotion and labeling.
- Assesses and communicates impact of legislation on the company’s business and products.
- Contributes to the company’s promotional review and labeling policy, standards development, and interpretation of regulations.
- Provides oversight to the Labeling Working Team and mentors junior labeling staff.
- Contributes to the company’s labeling policy and standards development and interpretation of regulations.
- Bachelor’s degree or equivalent required, preferably in a health/life sciences or related field.
- Must have a minimum of 7 years of experience as a regulatory reviewer of advertising and promotional materials within the pharmaceutical industry.
- Requires strong knowledge and understanding of global regulations and their interpretation relevant to prescription drug advertising, promotion, and labeling.
- Commercial launch and advisory comment process experience preferred.
- Must have working knowledge of the drug development process, including labeling development process.
- Requires understanding of XML and Electronic Document Management Systems to a sufficient level to support labeling documentation.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.