Associate Director, Regulatory Affairs - Advertising and Promotion

1000 Merck Sharp & Dohme LLC; North Wales (Montgomery County); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking an Associate Director of US Promotional Regulatory Affairs to review and approve all US promotional materials and provide regulatory expertise to commercial teams.

The role requires collaboration with FDA divisions (OPDP/APLB), cross-functional partners, and leadership in strategic regulatory planning. This hybrid position requires onsite work three days per week in Upper Gwynedd, PA or Rahway, NJ.

Qualifications

• BA/BS with emphasis in science, health care or related fields.
• Master’s/PhD/PharmD preferred with emphasis in science/health care.
• Minimum five years in pharma/biologics with regulatory focus.
• At least two years as primary regulatory reviewer of ads/promotional materials.
• Proven knowledge of FDA advertising and promotion regs for prescription products.

Responsibilities

• Review and approve US promotional materials for regulatory compliance.
• Serve as regulatory expert with legal, medical, and commercial teams.
• Collaborate with FDA divisions OPDP/APLB on complex questions/submissions.
• Develop regulatory strategies and solutions aligned with business goals.
• Provide regulatory guidance in US marketing strategy and programs.
• Train and coach team members on promotional regulatory topics.

Skills

FDA Regulations

Promotional Review

Regulatory Compliance

Cross-Functional Teamwork

Strategic Thinking

Negotiation

Stakeholder Management

US Regulatory Affairs

Data Analysis

Education

Bachelor's in Science

Master's/PhD/PharmD

Tools

eCTD

Job description

Role Overview

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 #GRACS #EligibleforERP

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 Strategies


• Regulatory Submissions


• Stakeholder Management


• Strategic Thinking


• US Regulatory Affairs

Preferred Skills

US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. 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: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts

Additional location(s) Compensation Information

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

Search Firm Representatives Please Read Carefully

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.

Employee Information

Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 11/21/2026 *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.

About Us

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.