Associate Manager CMC Regulatory Compliance

Merck•Billerica, MA

9d•Hybrid

About The Position

As the Associate Manager Regulatory CMC (RCMC), you are responsible for supporting all CMC regulatory activities including development, authoring and ownership of the CMC dossier Strategy Document, as well as all CMC Dossier types, their content and decision making on content, for assigned submissions worldwide, and serve as the liaison with the Global Healthcare Operations and R&D functions, being the contact person for all Regulatory CMC topics.

Requirements

Bachelor’s Degree in a Life Science discipline
1+ years of pharmaceutical industry or academia experience and regulatory or CMC knowledge

Nice To Haves

Master’s Degree or PhD
Strong written and verbal skills
Ability to develop and prepare successful regulatory CMC strategies and CMC dossiers
Experience in preparation of regulatory CMC documentation
Experience with life-cycle management activities in EU, USA and International
Practical experience in one of the following areas: manufacturing process development, transfers, validation or analytical development and control strategies

Responsibilities

Ensures global product oversight for the Regulatory CMC part of their product(s) / project(s)
Supports the development and definition of the Global Regulatory CMC strategy for development programs (pre-clinical to commercial application).
Leads and drives global regulatory CMC strategy for the assigned projects/products in target regions/countries.
This encompasses responsibility for the Regulatory CMC topics, risk assessment & mitigation, regulatory CMC strategic support and advice to interdisciplinary internal teams
Supports the preparation of HA meetings and Health Authority interactions on CMC topics
Responsible and accountable for driving all regulatory CMC activities for assigned projects/products.
Responsible for CMC Dossier types such as IMPD/IND, Health Authority Meeting Packages (incl. meeting request), variations, amendments, Module 1 CMC regulatory binding documents, Annual reports, CMC information in the Investigators Brochure, and Health Authority questions up to approval.
Provides the Global Regulatory CMC advice & expertise in cross-functional project teams.
Acts as liaison between Global Health Operations and R&D functions as single point of contact for all CMC topics.
Supports the development and provision of country specific regulatory CMC requirements for CMC dossier strategies and plans.
Reviews draft and newly released laws and guidance on behalf of the Company.
Leading and participation in internal as well as cross-functional, international initiatives.
Supports development and execute initiatives
Plans regulatory CMC activities and develops submission roll-out plans, in close collaboration with key stakeholders