Regulatory Affairs Director, FDA Submissions & Analytics

Merck & Co.; North Wales (Montgomery County); Hybride; USD 129 000 - 203 000; Plein temps

Avantages offerts par ce poste

Medical, dental, vision

401(k) plan

Paid holidays & vacation

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Regulatory knowledge

Project management

Negotiation

Analytical thinking

Team leadership

Communication

Formation

BA/BS degree

Outils

Veeva PromoMats

PowerBI

GenAI tools

Copilot

Google Gemini

Whiteboard

Description du poste

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.