Regulatory Affairs Associate Director — Hybrid & Analytics

MSD; North Wales (Montgomery County); Hybride; USD 129 000 - 203 000; Plein temps

Avantages offerts par ce poste

401(k) retirement benefits

Annual bonus

Long-term incentive

Hybrid work arrangements

Résumé du poste

MSD in the United States seeks a RegOps Associate Director to oversee regulatory submissions to FDA promotional review divisions. You will lead a team of contractors, coordinate with cross-functional teams, and drive analytics and predictive modeling to improve submission efficiency.

The role requires deep FDA knowledge, strong negotiation and project management skills, and a track record of compliant, timely submissions in a digital environment. Hybrid work arrangements apply.

Qualifications

• Minimum 5 years’ experience in pharmaceutical regulatory submissions or related QA/Regulatory roles.
• Proficiency with Veeva PromoMats workflows and reports; strong data reporting skills.
• Knowledge of FDA regulations governing promotional materials and submissions.
• Demonstrated ability to plan, prioritize, and manage multiple submissions in a digital environment.

Responsabilités

• Review, approve, and oversee regulatory submissions to FDA promotional review divisions.
• Lead analytics, reports, and dashboards to identify trends and optimize operations.
• Manage contractors delivering promotional materials for FDA submission.
• Collaborate with commercial, Publishing, Information Management, and Data Sciences teams.
• Provide strategic guidance for complex submissions and ensure compliance with company standards.

Connaissances

Regulatory Submissions

Regulatory Operations

FDA Regulations

Regulatory Compliance

Regulatory Coordination

PowerBI

Predictive Modeling

Negotiation

Data Management

Project Management

GenAI tools

Formation

B.A. or B.S. degree

Outils

Veeva PromoMats

PowerBI

GenAI tools

Copilot

GPT

Google Gemini

Description du poste

MSD in the United States seeks a RegOps Associate Director to oversee regulatory submissions to FDA promotional review divisions. You will lead a team of contractors, coordinate with cross-functional teams, and drive analytics and predictive modeling to improve submission efficiency.

The role requires deep FDA knowledge, strong negotiation and project management skills, and a track record of compliant, timely submissions in a digital environment. Hybrid work arrangements apply.