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Manager, CMC Regulatory Affairs – Global Rare Diseases
Chiesi GroupSeeking Regulatory Affairs Manager with CMC experience for Chiesi's Global Rare Diseases unit. Responsible for regulatory documents and submissions for product approvals.
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- 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
Comp & perks- Annual bonus scheme
- Comprehensive benefits package including pension
- Private medical insurance
- Wellbeing programme
- Flexible benefits programme
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
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Hard Skills & Tools
Regulatory Document ManagementCMC Regulatory RequirementsTechnical Transfer KnowledgeCTD M2 and M3 AuthoringGMP Compliance
Soft Skills
Attention to DetailMulti-taskingPrioritizationInterpersonal Skills