Regulatory Affairs Scientist

7 mesi fa

Sesto Fiorentino, Italia Lilly A tempo pieno

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Eli Lilly is seeking a **Regulatory Affairs Scientist**. This role will be part of the CMC Regulatory team at the manufacturing site in Sesto Fiorentino (FI), responsible for drug registration activities within the production facility and contract manufacturers. The position will have visibility into the entire manufacturing process of several type of products, including parenteral and biotechnological drugs.

**Main responsibilities**:

- To 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.
- Leads preparation, review, and finalization of CMC documents for global regulatory submissions, including submissions for manufacturing changes, new products, line extensions or renewals.
- Develops 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
- To ensure that Regulatory Tools are used and appropriately updated with accurate information and in a timely manner.
- Ensuring that all changes and deviations are reviewed and that any required regulatory activity carried out prior to implementation.
- Identifies and escalates CMC regulatory issues impacting product submissions across geographies.
- Provides regulatory guidance to Global Post Launch Optimization Teams, Change Control Boards, and Technical forums, and implements 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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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