Associate Director, Regulatory Affairs - Advertising and Promotion

Merck & Co.; North Wales (Montgomery County); Hybrid; USD 129,000 - 203,000; Full time

Job summary

Merck & Co. in the United States seeks a regulatory affairs professional to serve as liaison with FDA promotional review divisions (OPDP/APLB) and manage complex regulatory inquiries for advisory comment.

You will propose compliant regulatory strategies for promotional concepts, provide regulatory guidance for US marketing programs, and support commercial teams with material reviews to ensure alignment with US regulations and company standards.

Qualifications

• BA/BS in science, healthcare or related fields.
• Preferred MS/PhD/PharmD with emphasis in science/healthcare.

Responsibilities

• Serve as liaison with FDA promotional review divisions and manage complex regulatory questions.
• Propose compliant regulatory strategies that align with business objectives.
• Provide regulatory consultation in US marketing strategy and promos.
• Support commercial teams with regulatory guidance on materials and tactics.
• Participate in labeling and global regulatory meetings to support promotional messages.

Skills

FDA Regulations

Regulatory Submissions

Promotional Review

Cross-Functional Collaboration

Negotiation

Strategic Thinking

Stakeholder Management

US Regulatory Affairs

eCTD

Education

Bachelor's in Science

Master's/PhD/PharmD preferred

Tools

eCTD

Job description

Job Description

Role Overview

• 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

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.

Equal Employment Opportunity Statement

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

The primary location for this posting is:

USA - Pennsylvania - North Wales (Upper Gwynedd)

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$129,000.00 - $203,100.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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.

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 https://jobs.merck.com/us/en/compensation-and-benefits .

Additional location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

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

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.

Requisition ID

R424596