Senior Manager, Global Regulatory Affairs CMC

3w3 weeks ago

Merck Group

Billerica, US · Full-time · $134,200 – $202,200

About this role

The Senior Manager, Global Regulatory Affairs CMC is responsible for driving all CMC regulatory activities, including development and ownership of the CMC dossier strategy. This role serves as the primary regulatory CMC contact and liaison between Global Health Operations and R&D functions.

In this role, you will lead health authority interactions on CMC topics and provide strategic regulatory advice to cross-functional project teams. You will author and manage all CMC dossier types, from IMPDs and INDs to variations and renewals, ensuring global product oversight.

Join a diverse, inclusive team united as one for patients, working across therapeutic areas like Oncology, Neurology, and Fertility. The culture is flexible and collaborative, with colleagues across six continents innovating with science and technology to enrich lives.

This role provides great opportunities for personal development and career advancement within a global healthcare leader. You will be at the forefront of regulatory strategy, shaping the future of CMC submissions worldwide and directly impacting patient lives across therapeutic areas.

Requirements

Extensive experience in global regulatory affairs CMC for pharmaceutical products.
Proven ability to develop and execute CMC regulatory strategies for development and lifecycle management.
Strong knowledge of CMC dossier types including IMPD, IND, variations, and renewals.
Experience leading health authority interactions and representing regulatory affairs on CMC topics.
Ability to provide strategic regulatory advice to cross-functional project teams.
Demonstrated skill in acting as a liaison between global health operations and R&D functions.

Responsibilities

Ensure global product oversight for the regulatory CMC part of assigned products and projects.
Develop, define, and own the global regulatory CMC strategy for development and lifecycle management programs.
Lead health authority meetings and represent Global Regulatory Affairs on CMC topics.
Drive all regulatory CMC activities, including authoring and owning the CMC dossier strategy document and all dossier types (IMPD, IND, variations, renewals, etc.).
Provide global regulatory CMC advice and expertise to cross-functional project teams.
Act as liaison between Global Health Operations and R&D functions as the single point of contact for all CMC topics.
Assess regulatory CMC aspects of in- and out-licensing projects for business development due diligence.

Benefits

Hybrid work model with 3 days per week in the Billerica, MA office.
Diverse, inclusive, and flexible working culture.
Great opportunities for personal development and career advancement across the globe.
Purpose-driven work focused on helping patients at every stage of life.