Associate Manager CMC Regulatory Compliance

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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role:

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.

Location: Hybrid (3x/week) in Billerica, MA office

Global Product Oversight:

• Ensures global product oversight for the Regulatory CMC part of their product(s) / project(s)

Regulatory CMC strategy and Health Authority interactions:

• 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

Management of CMC Regulatory Activities; CMC Dossier generation:

• Responsible and accountable for driving all regulatory CMC activities for assigned projects/products.