Mgr/Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have

Description

Mgr/Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have

Job Responsibilities

The Chemistry Manufacturing Controls Manager will support the execution of global regulatory CMC strategies for marketed and development products. This role contributes to the preparation and submission of regulatory CMC documentation for a small molecule. This role also provides regulatory support and guidance to various cross‑functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into development and commercial programs.

• Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies.
• Contributes to the development of global regulatory CMC strategies for commercial products.
• Works with regulatory colleagues in development of global regulatory CMC strategies and submissions.
• Provides regulato...