Director / Sr. Director - Regulatory CMC (Remote Position)

Company: Gables Search Group
Location: Boston
Posted on: November 22, 2021

Job Description:

Our client, a growing Pharma company focused in Oncology, is looking for a Director/Sr. Director, Regulatory Affairs, CMC.

This position will be 100% Remote.

The Director/Sr. Director, Regulatory Affairs, CMC will also serve as a regulatory specialist on select project teams.



Responsibilities:



Develops and implements CMC regulatory strategies to facilitate the progress of R&D drug development and post-approval CMC changes
Organizes and manages CMC regulatory aspects of product development programs, product line-extension projects, and post-approval CMC activities
Serves as regulatory CMC representative including regulatory liaison with the FDA and other Health Authorities for submissions to include INDs, NDAs, CTAs and BLAs/MAAs

Responsible for CMC Regulatory development in preparation for filing of BLA/NDA documents.
Responsible for oversight and execution of CMC regulatory updates to regulatory authorities, FDA/EMA etc.



Requirements:



Pharmaceutical industry regulatory affairs experience within the CMC function at an organization with an FDA-regulated product.

Experience with Regulatory filings for IND, NDA and BLA. Strong experience with Biologic products and BLA submissions is A MUST.

Previous experience managing multiple projects simultaneously.
Experience developing and implementing strategies related to quality control of GMP materials (CMC)
Experience working with global teams and business partners.

Keywords: Gables Search Group, Boston , Director / Sr. Director - Regulatory CMC (Remote Position), Executive , Boston, Massachusetts