Associate Director, Regulatory Affairs

Merck; North Wales (Montgomery County); On-site; USD 180,000 - 240,000; Full time

Job summary

Merck, in the United States, seeks an experienced RegOps Associate Director to lead the review and oversight of regulatory submissions to FDA promotional review divisions (OPDP/APLB) for US products. You will coordinate with cross-functional teams and guide a team of contractors, ensuring submissions align with FDA regulations and company standards.

You will develop analytics, dashboards, and predictive insights to drive operational performance and partner with commercial teams to deliver

Qualifications

• Minimum 5 years' experience in the pharmaceutical industry supporting the promotional review process or related regulatory submission management.

Responsibilities

• Review, approve, and oversee regulatory submissions to FDA promotional review divisions for US products.
• Coordinate with Publishing, Information Management, Data Sciences and Regulatory Affairs teams.
• Develop analytics, reports, and dashboards; use predictive modeling to identify trends.
• Lead contractors supporting submission of promotional materials to FDA.
• Partner with commercial teams to propose compliant, rapid solutions aligned with business objectives.
• Maintain knowledge of evolving FDA regulations and submission criteria.
• Support Human Health Promotion Quality Management program activities and deviation investigations.

Skills

Regulatory submissions

Project management

Negotiation

Stakeholder collaboration

Analytical thinking

Regulatory intelligence

Education

Bachelor's degree

Tools

Veeva PromoMats

PowerBI

Copilot

Google Gemini

Whiteboard AI

Job description

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

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

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.

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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The primary location for this posting is: USA - Pennsylvania - North Wales (Upper Gwynedd)

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