Associate Director, Regulatory Affairs

MSD•North Wales, PA

1d•$129,000 - $203,100•Hybrid

About The Position

The RegOps Associate Director reports to the Regulatory Operations (RegOps) Director in OPAR. The role is responsible for reviewing, approving, and overseeing regulatory submissions to FDA promotional review divisions (OPDP/APLB) for all U.S. products, ensuring submissions comply with FDA regulations and company standards. The position serves as an operational point of contact and coordinates with Regulatory Affairs teams, including Publishing, Information Management, Data Sciences, and Regulatory Affairs Functions. It develops analytics, reports, and dashboards, uses predictive modeling to identify trends and insights, and prepares quarterly operational performance metrics. The role provides direction and performance management for contractors who support FDA submissions of promotional materials. The Associate Director partners with commercial teams and stakeholders to develop solutions for complex regulatory submissions, bringing the technological and operational expertise needed for rapid, compliant decisions aligned with business objectives. The role maintains knowledge of evolving FDA regulations and submission criteria for different promotional communications and materials, and ensures company standards and processes remain aligned. It also supports the Human Health Promotion Quality Management program, including deviation investigations and corrective actions, and works to improve process efficiency.

Requirements

Bachelor of Arts or Bachelor of Science degree.
At least 5 years of pharmaceutical industry experience supporting the promotional review process, 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 GenAI tools and agents, including PowerBI, Whiteboard, Copilot, GPT, and Google Gemini.
Excellent project management skills and ability to plan and prioritize submission work in a fully digital-enabled promotional environment to support business-critical activities.
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.
Demonstrated ability to negotiate and influence others effectively.
Proactive and solution-oriented approach, with the ability to manage multiple priorities simultaneously.
Skills listed 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 submissions comply 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 develop solutions for complex regulatory submissions and support rapid, compliant decisions aligned with business objectives.
Maintain knowledge of evolving FDA regulations and submission criteria for promotional communications and materials, and ensure company standards and processes are aligned.
Support Human Health Promotion Quality Management activities, deviation investigations, and corrective actions, while seeking to improve process efficiency.