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Sr Associate, Manufacturing Regulatory - Temporary (12 months contract)

Alfasigma
Pomezia, IT +1 more…Posted 4 weeks ago

Job Description

  • Assess regulatory impact of changes related to manufacturing sites, processes, and products
  • Plan and support activities associated with CMC (Chemistry, Manufacturing & Controls) variations and manufacturing site changes
  • Coordinate the collection, review, and organization of GMP documentation required for regulatory submissions
  • Draft and review documentation supporting CMC variations and manufacturing changes
  • Prepare product-specific regulatory declarations and contribute to Product Quality Reviews (PQRs)
  • Collaborate cross-functionally with Quality, Manufacturing, and other relevant departments to ensure alignment on regulatory strategies and timelines
  • Support continuous improvement initiatives to ensure ongoing compliance with regulatory standards

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    Sr Associate, Manufacturing Regulatory - Temporary (12 months contract) at Alfasigma | Renata