Regulatory Affairs Manager

Backfill of AMAGJP(phone number removed)

100% REMOTE - Needs to support PST time zone (flexible), must support ATO site hours
Need someone to can hit the ground running

Ideal candidate: someone with a mixed background not just lab but manufacturing and process development. This manager position within CMC will facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.

Title: Regulatory Project Coordinator (RPC)

Job Description:
o Assist Regional Regulatory Representative to support regional regulatory activities (e.g. IMPD development and submission, advisory committee meeting preparations)
o Create and maintain product regulatory history documents through IMR and appropriately archive all regulatory documents and agency communications.
o Ensure compliance with submissions regulatory agencies
o Coordinate QC of regulatory documentation (e.g. briefing packages)