Regulatory Affairs Lead: Submissions & Strategy (Hybrid)

MSD; Pennsylvania; Hybride; USD 129 000 - 203 000; Plein temps

Avantages offerts par ce poste

Annual bonus programmed

Long-term incentive

Résumé du poste

MSD in North Wales (PA) is seeking an Associate Director of Regulatory Affairs to lead regulatory submissions to FDA promotional review divisions. The role partners with cross-functional teams and oversees a contractor team to ensure timely, compliant submissions.

You will drive analytics, reporting, and predictive modeling to identify trends, with a focus on digital-enabled promotional environments and adherence to FDA regulations.

Qualifications

• Minimum 5 years’ experience in the pharmaceutical industry supporting the promotional review process or similar experience in Quality Assurance and/or Regulatory Submission Management.
• 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.

Responsabilités

• Review, approve, and oversee regulatory submissions to FDA promotional review divisions for U.S. products.
• Lead a team of contractors supporting the submission of promotional materials to FDA.
• Develop analytics, dashboards, and quarterly metrics to monitor operational performance.

Connaissances

Regulatory strategy

Regulatory submissions

Project management

FDA regulations

PowerBI

GenAI tools

Negotiation

Cross-functional collaboration

Formation

B.A. or B.S. degree

Outils

Veeva PromoMats

PowerBI

GenAI tools (e.g., Copilot, GPT)

Description du poste

MSD in North Wales (PA) is seeking an Associate Director of Regulatory Affairs to lead regulatory submissions to FDA promotional review divisions. The role partners with cross-functional teams and oversees a contractor team to ensure timely, compliant submissions.

You will drive analytics, reporting, and predictive modeling to identify trends, with a focus on digital-enabled promotional environments and adherence to FDA regulations.