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 Companys policies and support business objectives.

• Serve as the liaison and manage correspondence with FDAs 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 roles 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: Masters 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:

Preferred Skills:

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The salary range for this role is

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 employees 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.

We offer a comprehensive package of benefits. Available 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 can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

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