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Manager, CMC Regulatory Affairs – Global Rare Diseases

ComplianceComplianceFull TimeRemoteSeniorTeam 5,001-10,000H1B No SponsorCompany SiteLinkedIn

Location

Italy

Posted

8 days ago

Salary

€46.8K / year

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

Manager, CMC Regulatory Affairs – Global Rare Diseases

Chiesi Group

• Maintain or create CMC regulatory documents for product submissions • Manage CMC regulatory documents in collaboration with the Core team • Advise project teams on regulatory agency requirements • Review change control requests pertaining to CMC aspects • Agree on regulatory strategy for GRD products' life cycle • Maintain submission information and track commitments • Work with external CMOs and cross-functional teams • Support development of processes and Standard Operating Procedures • Represent GRDRA during GMP inspections • Keep abreast of current regulatory CMC requirements

Job Requirements

  • Minimum of a bachelor’s degree in a Scientific or Technical Discipline; Advanced Degree strongly preferred
  • 5+ years of Regulatory CMC experience
  • Advanced knowledge of current global CMC regulations, including ICH and regulatory requirements
  • Sound knowledge of manufacturing technical transfer and comparability regulatory requirements
  • Experience in authoring technical documents, CTD M2 and M3 sections
  • Proficient in the use of quality management software (e.g. TrackWise)
  • Strong attention to detail
  • Ability to multi-task and prioritize
  • Strong communication skills (oral, written, and interpersonal)
  • Ability to work independently and in a group setting

Benefits

  • Annual bonus scheme
  • Comprehensive benefits package including pension
  • Private medical insurance
  • Wellbeing programme
  • Flexible benefits programme

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