New · posted Nov 3
Merck · Pharmaceuticals
Associate Director, Regulatory Affairs - Advertising and Promotion
- North Wales, PA +1 more
- Hybrid
- Full-time
- Director
The role
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
What you need
Minimum Requirement
- B.A. or B.S. degree with an emphasis in science, health care or related fields.
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
Travel Requirements
10%
Preferrednice to have
- 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
Pay and benefits
$129,000 – $203,000 a year
Employer providedAdditional 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
Medical, dental and vision insurance
401(k) retirement benefits
Paid holidays
Vacation
Sick days
Annual bonus and long-term incentive
Where you'll work
North Wales, PA +1 moreHybridOpen in Maps (opens in a new tab)
Also posted for: Rahway, NJ
More jobs in North Wales, PA +1 moreWorking conditions
Not Indicated
Hazardous Material(s)
n/a
Employee Status
Regular
Relocation
No relocation
VISA Sponsorship
No
Flexible Work Arrangements
Hybrid
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.
Equal opportunity, accessibility and legal noticesMerck's statements, word for word
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. Please click here if you need an accommodation during the application or hiring process.
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:
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.
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.
Job intelligence
The context around this role
Live data · November 3, 2026
Salary intelligence
How the pay compares
This role's midpoint is 19% below the US median for Labeling & Promotion roles at this level.
This roleEmployer provided
Director roles in the US38 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $129,000 | — | $203,000 |
| All US (middle half) | $198,500 | $205,500 | $217,625 |
This role: Merck's own published range. Comparisons: the base pay employers published on open Labeling & Promotion roles at the same level on Regulatory Jobs, November 3, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Labeling & Promotion
The general path across 80 open Labeling & Promotion roles on Regulatory Jobs, with the titles they carry most. Not Merck's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership6
- Regulatory submissions5
- GMP and compliance4
- Documentation and SOPs2
- Clinical trial conduct2
- Lab testing and methods1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDAeCTD(official source, opens in a new tab)The electronic Common Technical Document format for submissions
- FDAFDA OPDP(official source, opens in a new tab)The Office of Prescription Drug Promotion, which reviews advertising and promotion
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Merck on Regulatory Jobs
- 26
- Open roles
- 26
- Distinct roles
- 5
- Locations
By discipline
- Clinical19 73%
- Regulatory6 23%
- Quality1 4%
By level
- Director21 81%
- Senior & Principal4 15%
- VP & Executive1 4%
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Associate Director, Regulatory Affairs - Advertising and Promotion at Merck
Applications close November 21. $129K–$203K a year, employer provided.