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 serves 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, 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. Qualifications, Skills & Experience Minimum Requirement B.A. or B.S. degree with an emphasis in science, health care or related fields. Preferred 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. Location US and Puerto Rico residents only. San Francisco residents only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance. Los Angeles residents only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Compensation & Benefits Salary range: $129,000.00 – $203,100.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at Equal Employment Opportunity As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit the EEOC website. #J-18808-Ljbffr Merck & Co.