Assoc Director, Regulatory Affairs - Advertising and Promotion

Job Description

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 

Please note this is a hybrid position. Candidates must be able to meet the role's hybrid requirement of working onsite three days per week in either Upper Gwynedd, PA or Rahway, NJ

 

Qualifications, Skills & Experience

Minimum Requirement:  B.A. or B.S. degree with an emphasis in science, health care or related fields. 

Preferred: Master’s, PhD or PharmD 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 

Required Skills:

Clinical Trials, Cross-Functional Teamwork, Data Analysis, Detail-Oriented, Electronic Common Technical Document (eCTD), FDA Regulations, Negotiation, Pharmaceutical Industry, Promotional Review, Regulatory Compliance, Regulatory Labeling, Regulatory Strategies, Regulatory Submissions, Stakeholder Management, Strategic Thinking, US Regulatory Affairs

Preferred Skills:

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