Associate Director, Regulatory Affairs

MSD; North Wales (Montgomery County); Híbrido; USD 129.000 - 203.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) retirement benefits

Annual bonus

Long-term incentive

Hybrid work arrangements

Descripción de la vacante

MSD in the United States seeks a RegOps Associate Director to oversee regulatory submissions to FDA promotional review divisions. You will lead a team of contractors, coordinate with cross-functional teams, and drive analytics and predictive modeling to improve submission efficiency.

The role requires deep FDA knowledge, strong negotiation and project management skills, and a track record of compliant, timely submissions in a digital environment. Hybrid work arrangements apply.

Formación

• Minimum 5 years’ experience in pharmaceutical regulatory submissions or related QA/Regulatory roles.
• Proficiency with Veeva PromoMats workflows and reports; strong data reporting skills.
• Knowledge of FDA regulations governing promotional materials and submissions.
• Demonstrated ability to plan, prioritize, and manage multiple submissions in a digital environment.

Responsabilidades

• Review, approve, and oversee regulatory submissions to FDA promotional review divisions.
• Lead analytics, reports, and dashboards to identify trends and optimize operations.
• Manage contractors delivering promotional materials for FDA submission.
• Collaborate with commercial, Publishing, Information Management, and Data Sciences teams.
• Provide strategic guidance for complex submissions and ensure compliance with company standards.

Conocimientos

Regulatory Submissions

Regulatory Operations

FDA Regulations

Regulatory Compliance

Regulatory Coordination

PowerBI

Predictive Modeling

Negotiation

Data Management

Project Management

GenAI tools

Educación

B.A. or B.S. degree

Herramientas

Veeva PromoMats

PowerBI

GenAI tools

Copilot

GPT

Google Gemini

Descripción del empleo

Job Description

Reports to Regulatory Operations (RegOps) Director in OPAR. 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

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

Equal Employment Opportunity

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.

Compensation

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.

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

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.

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

Employment Details

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

About the Company

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.