Regulatory Affairs Consultant
1 settimana fa
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 35,000 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.
**Purpose**:
The purpose of the Regulatory Affairs Consultant - Contractor role is to support Regulatory Team in activities ruled out by the EU Regulations and Italian Law (e.g. 219/06).
**Primary Responsibilities**:
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Italian Regulatory Team
- Managing regulatory documents for decentralized, mutual recognition and centralized procedures.
- Preparing documentation for regulatory Authorities (AIFA/EMA) in support to the Italian Affiliate Regulatory managers
- Archiving any regulatory documents in the physical Library in Sesto: e.g.: Variations of medicinal products, German Translations etc.
- Managing all the correspondence from/to AIFA (but the Price and Reimbursement one) and concerned Lilly departments (i.e. Regulatory, Sesto Manufacturing, Pharmacovigilance, Scientific Informations, Quality, Counterfeiting).
- Managing and archiving correspondence of the documentation received from AIFA’s Area Officine (request for certificates of pharmaceutical products - CPP - and GMP etc.).
- Ensure administrative support related to the publication of regulatory documents (product’s Variations of non-centralized products) in Gazzetta Ufficiale as ruled out by the Italian law.
- Support the Regulatory Team in the Audits
- Daily inspection of AIFA website, Gazzetta Ufficiale website and Farmindustria Circulars on Regulatory topics.
Italy Hub Regulatory Team
- Creating, managing and updating the digital collaboration spaces (Teams, Sharepoint, others) to be used by the members of the Italy Hub Regulatory Team
- Creating and updating dashboards on the Regulatory activities across the Hub.
- Administrative Support in updating Italy Hub Regulatory Team calendar of activities (Lead Team, full team, 1:1, etc.)
- Administrative support in organizing Italy Hub Regulatory Team meetings
**Minimum Qualification Requirements**:
- Good knowledge of written and spoken English language.
- Good knowledge of European/National pharmaceutical legislation with regards to relevant EU and local regulatory guidelines, directives and laws.
**Other Information/Additional Preferences**:
- Interpersonal relationship and good capabilities to work in Team
- Attitude in managing relationship with civil servant such as representatives from National Regulatory Authorities
- Good knowledge of main softwares and PC programs.
- Customer focus and outcome orientation.
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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