Associate Director, Regulatory Affairs

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

Benefits offered by this job

Medical, dental, vision

401(k) plan

Paid holidays & vacation

Job summary

Merck & Co., Inc. is seeking a RegOps Associate Director to oversee regulatory submissions to FDA promotional review divisions in the U.S., coordinating with multiple regulatory teams and ensuring compliance with FDA and company standards.

The role focuses on analytics, predictive modeling, and quarterly metrics to track operational performance, with leadership of a contractor team and collaboration with commercial stakeholders to drive rapid, compliant decisions.

Qualifications

• Minimum 5 years' experience in the pharmaceutical industry supporting the promotional review process.
• Proficiency with Veeva PromoMats software workflows and reports.
• Proficiency with data reporting software and GenAI tools including PowerBI, Whiteboard, Copilot, GPT, Google Gemini.
• Excellent project management skills to plan and prioritize submission work in a fully digital environment.
• Understanding of FDA regulations, processes and systems relating to advertising and promotion for prescription products.
• Strong interpersonal and negotiation skills and ability to demonstrate strategic and analytic thinking.
• Proactive and solution-oriented with ability to manage multiple priorities.

Responsibilities

• Review, approval, and oversight of regulatory submissions to FDA promotional divisions.
• Coordinate with Regulatory Affairs teams including Publishing, Information Management, Data Sciences.
• Develop analytics, reports, and dashboards; prepare quarterly metrics.
• Provide direction and performance management for a team of contractors.
• Partner with commercial teams to propose creative regulatory submission solutions.
• Maintain knowledge of evolving FDA regulations for different promotion materials.
• Support Human Health Promotion Quality Management and deviation investigations.

Skills

Regulatory knowledge

Project management

Negotiation

Analytical thinking

Team leadership

Communication

Education

BA/BS degree

Tools

Veeva PromoMats

PowerBI

GenAI tools

Copilot

Google Gemini

Whiteboard

Job description

Job Description

• The RegOps Associate Director is responsible for the review, approval, and oversight of regulatory submissions to the promotional review divisions of FDA (OPDP/APLB) for all U.S. products. Ensures regulatory submissions are aligned with FDA regulations and our Company standards.
• Functions as a point of contact for operational activities and coordinates with other Regulatory Affairs teams, including Publishing, Information Management, Data Sciences, and Regulatory Affairs Functions.
• Develops analytics, reports, and dashboards; leverages predictive modeling to identify trends and insights; and prepares quarterly metrics to track operational performance.
• Provides direction and performance management for a team of contractors supporting the submission of promotional materials to FDA.
• Partners with commercial teams and stakeholders and proposes creative solutions for complex regulatory submissions and provides the required technological and operational expertise needed to make rapid and compliant decisions aligned with business objectives.
• Maintains knowledge of evolving FDA regulations and submission criteria for different types of promotion communications and materials, ensures our Company standards and processes are in alignment.
• Supports activities generated from the Human Health Promotion Quality Management program to ensure materials are of high quality and comply with FDA and our Company standards, guidelines and regulations. Supports deviation investigations and corrective actions and strives to make the process more efficient.

Education

• Minimum Requirement:- B.A. or B.S. degree

Required Experience and Skills

• Minimum 5 years' experience in the pharmaceutical industry supporting the promotional review process or similar experience in Quality Assurance and/or Regulatory Submission Management, Regulatory Publishing, Submission planning and filing of materials with FDA or health authorities.
• -Proficiency with Veeva PromoMats software workflows and reports.
• -Proficiency with data reporting software and GenAI tools and agents, including PowerBI, Whiteboard, Copilot, GPT, Google Gemini.
• -Excellent project management skills and ability to plan and prioritize submission work in a fully digital-enabled promotional environment to effectively support business critical activities.
• -Understanding of FDA regulations, processes and systems relating to advertising and promotion for prescription products.
• -Strong interpersonal and negotiation skills and the ability to demonstrate strategic and analytic thinking
• -Demonstrated ability to negotiate and influence others effectively.
• -Proactive and solution-oriented, with the ability to manage multiple priorities simultaneously.

Required Skills

Adaptability, Adaptability, Advertising, Data Management, Decision Making, Deviation Investigations, Deviation Management, Deviation Reporting, Employee Training Programs, FDA Regulations, FDA Submissions, Health Program Management, Marketing Materials, Negotiation, Pharmaceutical Industry, Pharmaceuticals Marketing, Pharmacovigilance, Policy Implementation, Predictive Modeling, Regulatory Affairs Management, Regulatory Compliance, Regulatory Coordination, Regulatory Information Management, Regulatory Labeling, Regulatory Operations {+ 5 more}

Preferred Skills

Current Employees apply HERE

Current Contingent Workers apply HERE

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.

Equal Employment Opportunity

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:

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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)

Salary Range

$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.

Benefits

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 locations

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.

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 Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

No Travel Required

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

11/1/2026

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

R423700