Senior Associate, Qa Compliance

Alcon

Not specified
Cmc documentation authoring and maintenance
Global regulatory submission support
Health authority query management
Alcon is seeking a Senior Associate for QA Compliance, focusing on authoring and maintaining Chemistry, Manufacturing, and Controls (CMC) documentation to support regulatory submissions. The role emphasizes collaboration with global regulatory teams, managing submissions, and ensuring compliance with evolving guidelines

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 review CMC sections of regulatory dossiers for new product filings, variations, and renewals.
  • You will partner with global RA teams to align submission strategies and coordinate responses to Health Authority queries.

Matching Summary

Match Score: 85

Alcon is seeking a Senior Associate for QA Compliance, focusing on authoring and maintaining Chemistry, Manufacturing, and Controls (CMC) documentation to support regulatory submissions. The role emphasizes collaboration with global regulatory teams, managing submissions, and ensuring compliance with evolving guidelines.

Skills & Requirements

Must-have

  • CMC documentation authoring and maintenance
  • Global regulatory submission support
  • Health Authority query management
  • Regulatory impact assessment expertise
  • ICH EMA FDA PMDA WHO compliance knowledge

Nice-to-have

  • Strong technical writing skills
  • Experience with eCTD tools and Veeva Vault
  • Ability to manage multiple projects under tight timelines
  • Collaboration across global and local teams
  • Continuous improvement mindset in compliance

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)
  • Familiarity with manufacturing processes, quality systems, and GMP requirements

Work Rights

Not specified

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