Associate Director, Regulatory Affairs

Merck • North Wales, PA

6d • $129,000 - $203,100 • Hybrid

About The Position

The RegOps Associate Director reports to the Regulatory Operations (RegOps) Director in OPAR. This role reviews, approves, and oversees regulatory submissions to FDA promotional review divisions (OPDP/APLB) for all U.S. products, ensuring that submissions align with FDA regulations and company standards. The position serves as an operational contact and coordinates with Regulatory Affairs teams, including Publishing, Information Management, Data Sciences, and Regulatory Affairs Functions.

The Associate Director develops analytics, reports, and dashboards, uses predictive modeling to identify trends and insights, and prepares quarterly metrics to track operational performance. The role provides direction and performance management for contractors who support FDA submissions of promotional materials. It also partners with commercial teams and stakeholders to develop creative solutions for complex submissions and supply technological and operational expertise to support rapid, compliant decisions aligned with business objectives.

The position maintains knowledge of evolving FDA regulations and submission criteria for promotional communications and materials, and ensures company standards and processes remain aligned. It supports the Human Health Promotion Quality Management program, including efforts to ensure material quality and compliance, deviation investigations, and corrective actions, while seeking to improve process efficiency.

Requirements

• B.A. or B.S. degree.
• At least 5 years of experience in the pharmaceutical industry supporting promotional review processes, or similar experience in Quality Assurance, Regulatory Submission Management, Regulatory Publishing, or 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 generative AI tools and agents, including PowerBI, Whiteboard, Copilot, GPT, and Google Gemini.
• Excellent project management skills and ability to plan and prioritize submissions in a fully digital-enabled promotional environment.
• Understanding of FDA regulations, processes, and systems relating to advertising and promotion for prescription products.
• Strong interpersonal and negotiation skills, with strategic and analytical thinking ability.
• Demonstrated ability to negotiate and influence others effectively.
• Proactive, solution-oriented approach and ability to manage multiple priorities simultaneously.
• Required skills include 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, and regulatory operations.

Responsibilities

• Review, approve, and oversee regulatory submissions to FDA promotional review divisions (OPDP/APLB) for all U.S. products.
• Ensure regulatory submissions align with FDA regulations and company standards.
• Coordinate operational activities with Regulatory Affairs teams, including Publishing, Information Management, Data Sciences, and Regulatory Affairs Functions.
• Develop analytics, reports, and dashboards; use predictive modeling to identify trends and insights; and prepare quarterly operational performance metrics.
• Provide direction and performance management for contractors supporting FDA submissions of promotional materials.
• Partner with commercial teams and stakeholders to propose solutions for complex regulatory submissions and support rapid, compliant decisions.
• Maintain knowledge of FDA regulations and submission criteria for promotional communications and materials, and ensure company standards and processes remain aligned.
• Support the Human Health Promotion Quality Management program, including quality and compliance efforts, deviation investigations, corrective actions, and process efficiency improvements.

Benefits

• Medical, dental, and vision healthcare and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior