Associate Director, Advertising & Promotion Regulatory Affairs (Hybrid)

Job Description Reports to the Director/Senior Director in the Office of Promotion and Advertising Review (OPAR). The Associate Director is responsible for the review and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams 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 Office of Promotion and Advertising Review (OPDP)/Advertising and promotional labeling branch (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 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 of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters, and policy issues affecting the pharmaceutical/biologics industry. Communicate significant changes in FDA perspective to relevant stakeholders. Serve as a mentor within the department. 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. Required Experience and Skills: Minimum of five years of pharmaceutical/biologics industry or related experience with an emphasis in regulatory or scientific disciplines, including a minimum of two years of direct experience as the primary 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. Minimum education required: 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. Employee Status:

Regular Relocation:

No relocation VISA Sponsorship:

No Travel Requirements:

10% Flexible Work Arrangements:

Hybrid Job Posting End Date:

11/14/2024 *A job posting is effective until 11:59:59PM on the day

BEFORE

the listed job posting end date. Please ensure you apply to a job posting no later than the day

BEFORE

the job posting end date.

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