Manager, CMC Regulatory Affairs – Global Rare Diseases
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Job Description
Seeking Regulatory Affairs Manager with CMC experience for Chiesi's Global Rare Diseases unit. Responsible for regulatory documents and submissions for product approvals.
Responsibilities:
- 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:
- 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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