New · posted Nov 6
Merck · Pharmaceuticals
Director, Regulatory Affairs, Promotion and Advertising Review (OPAR)
- North Wales, PA +1 more
- Hybrid
- Full-time
- Director
The role
The Individual Contributor Director is responsible for the review and approval of 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. Functions at an advanced and independent level.
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.
Proactively partners with the review team, compliance, and commercial colleagues to ensure a cohesive and integrated regulatory strategy from early development through approval and marketing.
Lead the development of assigned products’ promotional regulatory strategy, including the rationale for Global Target Product Information (GTPI). Provide solutions to complex regulatory scenarios and content.
Identify and provide solutions during 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 an expert understanding of FDA regulations governing advertising and promotion. Proactively provides solutions to complex regulatory and commercial needs in a compliant manner, consistent with US FDA regulations, PhRMA Code and Principles, and company policy and procedures.
Is seen as a leader and is sought out by peers. Creates capacity to provide support to team members. Proactively seeks opportunities to take on more complex projects and provide promotional regulatory training and coaching to team members. Mentors’ new hires.
Lead the development of departmental strategic initiatives to drive effective, compliant promotional regulatory review.
What you need
Education
Preferred: Master’s, PhD or PharmD degree with an emphasis in science, health care or related fields.
Required Skills
Advertising Compliance, Communication, Cross-Functional Teamwork, Detail-Oriented, FDA Regulations, Negotiation, Pharmaceutical Advertising, PhRMA Code, Policy Implementation, Problem Solving, Regulatory Affairs, Regulatory Risk, Regulatory Strategies, Strategic Thinking, Team Collaboration
- Minimum of ten years of pharmaceutical/biologics industry or related experience with an emphasis in regulatory or scientific disciplines, including a minimum of five years of direct experience as the primary reviewer of advertising and promotional materials.
- Demonstrated in-depth understanding of FDA regulations and our Company's policies and procedures related to promotion development and implementation, as well as promotion review processes.
- Demonstrated strong diplomacy, interpersonal, and negotiation skills. Recognized as a consensus builder with strong strategic and analytical thinking capabilities.
- Proven track record of effective collaboration with external stakeholders, including FDA branches (OPDP, APLB), alliance relationships with peer companies, and external consortia and trade organizations such as DIA.
- In-depth understanding of the clinical development process, regulatory policy, labeling development, and FDA approval processes.
- Demonstrated ability to identify solutions to complex promotional regulatory issues.
- Demonstrated superior verbal and written communication skills.
Travel Requirements
10%
Valid Driving License
Yes
Pay and benefits
$173,000 – $273,000 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 and compassionate 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
11/19/2026
*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.
Minimum Requirement: B.A. or B.S. degree with an emphasis in science, health care or related fields.
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:
$173,200.00 - $272,600.00
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 6, 2026
Salary intelligence
How the pay compares
This role's midpoint is 9% above the US median for Labeling & Promotion roles at this level.
This roleEmployer provided
Director roles in the US41 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $173,000 | — | $273,000 |
| All US (middle half) | $187,500 | $205,500 | $218,500 |
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 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Labeling & Promotion
The general path across 87 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 22 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership8
- Regulatory submissions5
- GMP and compliance4
- Documentation and SOPs3
- Clinical trial conduct2
- Lab testing and methods1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Labeling & Promotion work in pharmaceuticals, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDAFDA OPDP(official source, opens in a new tab)The Office of Prescription Drug Promotion, which reviews advertising and promotionNamed in the posting
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- FDA21 CFR Part 202(official source, opens in a new tab)Prescription drug advertising: fair balance and required information
- FDAFDA prescription drug labeling resources(official source, opens in a new tab)Physician Labeling Rule (PLR) format and content of prescribing information
- FDAFDA Structured Product Labeling(official source, opens in a new tab)The SPL standard for submitting labeling content to FDA
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- FDAFDA REMS(official source, opens in a new tab)Risk Evaluation and Mitigation Strategies for drugs with serious safety concerns
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDAFDA eCTD(official source, opens in a new tab)The electronic Common Technical Document format for drug and biologic submissions
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- FDADrug Supply Chain Security Act(official source, opens in a new tab)Product tracing, verification and serialization across the US drug supply chain
- Health CanadaCanada Food and Drug Regulations(official source, opens in a new tab)Health Canada's regulations for drugs, including GMP (Part C, Division 2)
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
- CMSOpen Payments (Sunshine Act)(official source, opens in a new tab)Reporting of manufacturer payments to physicians and teaching hospitals
- HHS-OIGHHS-OIG General Compliance Program Guidance(official source, opens in a new tab)The federal government's guide to healthcare compliance programs and the anti-kickback statute
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Merck on Regulatory Jobs
- 45
- Open roles
- 45
- Distinct roles
- 8
- Locations
By discipline
- Clinical28 62%
- Quality10 22%
- Regulatory7 16%
By level
- Director34 76%
- Associate & Specialist6 13%
- Senior & Principal4 9%
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Director, Regulatory Affairs, Promotion and Advertising Review (OPAR) at Merck
Applications close November 19. $173K–$273K a year, employer provided.