Regulatory Affairs Specialist
3 settimane fa
We're seeking a highly skilled Regulatory Affairs Scientist to join our team at Eli Lilly.
This role will be part of the CMC Regulatory team at our manufacturing site in Sesto Fiorentino, Italy, responsible for drug registration activities within the production facility and contract manufacturers.
Main responsibilities:
- Provide regulatory support for products/contract manufacturers and projects as required, by preparing and maintaining the appropriate regulatory submission documentation needed to obtain/maintain Marketing Authorisation.
- Lead the preparation, review, and finalization of CMC documents for global regulatory submissions, including submissions for manufacturing changes, new products, line extensions or renewals.
- Develop global CMC regulatory strategies in collaboration with other regulatory, MS&T, Quality, and project personnel to enable timely completion of submission milestones leading to health authority approval.
- Ensure that Regulatory Tools are used and appropriately updated with accurate information and in a timely manner.
- Ensure that all changes and deviations are reviewed and that any required regulatory activity carried out prior to implementation.
- Identify and escalate CMC regulatory issues impacting product submissions across geographies.
- Provide regulatory guidance to Global Post Launch Optimization Teams, Change Control Boards, and Technical forums, and implement regulatory strategies that result in successful product updates.
- Ensure that all applicable GMP documents are in compliance with current regulatory commitments.
- Review/Approve the Regulatory supporting documents.
Required qualifications:
- Master's degree in a scientific field (CTF, Biology, Chemistry)
- Excellent command of the English language
- Demonstrated CMC Regulatory knowledge/experience, including EU/US and ICH guidelines
- Excellent communication skills and ability to influence
- Willingness to travel as requested
- Appreciation of cultural diversity
- Attention to detail.
Lilly is an equal opportunities employer and welcomes applications from all qualified candidates.
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