Regulatory Affairs Manager Job at Aequor, Thousand Oaks, CA

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  • Aequor
  • Thousand Oaks, CA

Job Description

Backfill of AMAGJP00011619 and AMAGJP00012367


*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)

Job Tags

Remote job, Flexible hours,

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