Associate Director, Regulatory Submissions & Operations

Merck; North Wales (Montgomery County); Presencial; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

Merck, in the United States, seeks an experienced RegOps Associate Director to lead the review and oversight of regulatory submissions to FDA promotional review divisions (OPDP/APLB) for US products. You will coordinate with cross-functional teams and guide a team of contractors, ensuring submissions align with FDA regulations and company standards.

You will develop analytics, dashboards, and predictive insights to drive operational performance and partner with commercial teams to deliver

Formación

• Minimum 5 years' experience in the pharmaceutical industry supporting the promotional review process or related regulatory submission management.

Responsabilidades

• Review, approve, and oversee regulatory submissions to FDA promotional review divisions for US products.
• Coordinate with Publishing, Information Management, Data Sciences and Regulatory Affairs teams.
• Develop analytics, reports, and dashboards; use predictive modeling to identify trends.
• Lead contractors supporting submission of promotional materials to FDA.
• Partner with commercial teams to propose compliant, rapid solutions aligned with business objectives.
• Maintain knowledge of evolving FDA regulations and submission criteria.
• Support Human Health Promotion Quality Management program activities and deviation investigations.

Conocimientos

Regulatory submissions

Project management

Negotiation

Stakeholder collaboration

Analytical thinking

Regulatory intelligence

Educación

Bachelor's degree

Herramientas

Veeva PromoMats

PowerBI

Copilot

Google Gemini

Whiteboard AI

Descripción del empleo

Merck, in the United States, seeks an experienced RegOps Associate Director to lead the review and oversight of regulatory submissions to FDA promotional review divisions (OPDP/APLB) for US products. You will coordinate with cross-functional teams and guide a team of contractors, ensuring submissions align with FDA regulations and company standards.

You will develop analytics, dashboards, and predictive insights to drive operational performance and partner with commercial teams to deliver