The Senior Associate, QA Compliance position at company 467 involves authoring and maintaining Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory submissions, with a focus on collaboration across global and local regulatory teams. The ideal candidate should have extensive experience in regulatory affairs within the pharmaceutical industry, particularly in CMC, as well as strong technical writing and analytical skills
Job Summary
This role is critical in bridging site operations with global regulatory strategies to ensure compliance while enabling innovation.
The successful candidate will author and maintain Chemistry, Manufacturing, and Controls (CMC) documentation to support global and local regulatory submissions.
Key responsibilities include managing responses to Health Authority queries and conducting regulatory impact assessments for site changes.
Matching Summary
Match Score: 85
The Senior Associate, QA Compliance position at company 467 involves authoring and maintaining Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory submissions, with a focus on collaboration across global and local regulatory teams. The ideal candidate should have extensive experience in regulatory affairs within the pharmaceutical industry, particularly in CMC, as well as strong technical writing and analytical skills.
Skills & Requirements
Must-have
CMC documentation authoring
Global regulatory submission management
Health Authority query response
Change control impact assessment
ICH EMA FDA PMDA WHO compliance
Nice-to-have
Veeva Vault proficiency
eCTD tool expertise
Continuous improvement mindset
Strong technical writing skills
Cross-functional collaboration
Key Requirements
Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or Life Sciences
10+ years of experience with recent 3-5 years in Regulatory Affairs CMC focus
Experience with global regulatory submissions and country-specific filings
Familiarity with manufacturing processes quality systems and GMP requirements