Assoc Director, Regulatory Affairs - Advertising and Promotion
About The Position
The Associate Director is responsible for the review and approval of all US promotional materials and serving as the promotional regulatory expert with legal, medical and commercial colleagues to ensure that promotional practices are consistent with regulatory guidelines, our Company's policies, and support business objectives. Serve as the liaison and manage correspondence with FDA’s promotional review divisions OPDP/APLB, including complex regulatory questions and submissions for advisory comment. Propose creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk. Provide regulatory consultation in the development and implementation of US marketing strategy and promotional programs. Support the US commercial teams, including relevant stakeholders, by participating in strategy discussions and extended team meetings and providing regulatory guidance and perspective on marketing strategies and promotion objectives and tactics. Provide promotional regulatory input on concepts and draft materials to help ensure promotional materials are aligned with U.S. promotional regulations, corporate standards and policies and business objectives. Actively participate in labeling and global regulatory team meetings to ensure support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of study results in U.S. promotion. Maintain current awareness and understanding of FDA advisory correspondence, evolving FDA regulations and guidance documents, FDA enforcement letters and policy issues affecting the pharmaceutical/biologics industry and clearly articulate regulatory rationale. Ability to take on more complex projects and provide promotional regulatory training and coaching to team members. Contribute to the development of departmental strategic initiatives to drive effective, compliant promotional regulatory review.
Requirements
- B.A. or B.S. degree with an emphasis in science, health care or related fields
- Minimum of five years of pharmaceutical/biologics industry or related experience with an emphasis in regulatory or scientific disciplines
- Minimum of two years of direct experience as the primary regulatory reviewer of advertising and promotional materials
- Demonstrated knowledge of FDA regulations relating to advertising and promotion for prescription products
- Proactive with strong cross-functional collaboration skills
- Demonstrated history of successful interactions with the promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launch
- Understanding of the product development and labeling process
- Excellent verbal and written communication skills
- Attention to detail and ability to manage multiple priorities simultaneously
- Strong interpersonal skills with ability to demonstrate strategic and analytical thinking
- Demonstrated ability to negotiate and influence others effectively
Nice To Haves
- Master’s, PhD or PharmD degree with an emphasis in science, health care or related fields
- Current Employees apply HERE
- Current Contingent Workers apply HERE
- US and Puerto Rico Residents Only
- San Francisco Residents Only
- Los Angeles Residents Only
- Search Firm Representatives Please Read Carefully
Responsibilities
- Review and approval of all US promotional materials
- Serve as the promotional regulatory expert with legal, medical and commercial colleagues
- Ensure promotional practices are consistent with regulatory guidelines, company policies, and support business objectives
- Serve as the liaison and manage correspondence with FDA’s promotional review divisions OPDP/APLB
- Manage complex regulatory questions and submissions for advisory comment
- Propose creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts
- Provide regulatory consultation in the development and implementation of US marketing strategy and promotional programs
- Support US commercial teams by participating in strategy discussions and extended team meetings
- Provide regulatory guidance and perspective on marketing strategies and promotion objectives and tactics
- Provide promotional regulatory input on concepts and draft materials
- Ensure promotional materials are aligned with U.S. promotional regulations, corporate standards and policies and business objectives
- Actively participate in labeling and global regulatory team meetings
- Ensure support for anticipated promotional messages and claims in clinical trial design and product labeling
- Maintain current awareness and understanding of FDA advisory correspondence, evolving FDA regulations and guidance documents, FDA enforcement letters and policy issues
- Clearly articulate regulatory rationale
- Take on more complex projects
- Provide promotional regulatory training and coaching to team members
- Contribute to the development of departmental strategic initiatives
Benefits
- medical
- dental
- vision healthcare
- other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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What This Job Offers
Job Type
Full-time
Career Level
Director
