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Regional Labelling Coordinator
hace 3 semanas
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.
**_ Organization Overview:_**
The Regional Labelling Coordinator (RLC) will be part of a regional team, supporting the emerging markets within the International Region from product labelling perspective, while the specific position will focus on the Latin-America.
**_Responsibilities:_**
The purpose of the RLC role is to drive the timely and high-quality implementation and maintenance of product labelling, and to coordinate, monitor and support International Affiliates and External Alliance Partnerships where Country Specific (CS) or Multi Market Labelling (MML) is used. The RLC should develop collegial, mutually productive relationships across Global and Affiliate Regulatory, External Alliance Business Partners, Printed Packaging Development, Manufacturing / Supply Chain, and other cross-functional partners and utilizes regulatory labelling and process expertise across the organization and geographies to facilitate timely product launches, drive consistency and influence effective change management.
In addition, the RLC coordinates and supports External Business Alliance Partners with the preparation of complete regulatory submission packages for new and revised Product Information (MML & CS) in line with Reference Country labelling to meet internal and external expectations or prepares and provides such regulatory submission packages to Lilly Affiliates.
- Serve as a labelling resource for regulatory to develop and gain support for strategies and concepts that will deliver timely labelling for both new and marketed products._
- Lead, partner, and influence labelling-related activities throughout the product lifecycle to drive timely implementation of labelling changes ensuring regulator and internal timelines are met.
- Liaise with Affiliates, GRA International Scientists and Manufacturing/Supply Chain on the creation of new product labels to support product launch
- Liaise with cross-functional partners to manage multiple changes occurring simultaneously (e.g., CMC or Manufacturing changes impacting labelling).
- Develop submission and implementation plans and propose opportunities for bundling changes for more efficient implementation, when applicable.
- Participate in cross-functional Launch meetings to help achieve efficient new product launches in the region.
- Maintain understanding and expertise of local and if appropriate regional regulations related to labelling implementation.
- Routinely share labelling knowledge with key customers. Become the key contact person for affiliates and alliance teams on labelling submission strategies and implementation questions.
- Provide guidance and coordinate site-affiliate / global supply-affiliate discussions on labelling related projects.
- Specific Labelling tasks as applicable (MML & CS):_
- Act as a delegate for Affiliate labelling responsible person (ALRP) covering implementation responsibilities outlined in the Labelling Development and Maintenance standard.
- Provide oversight for the truth copy development & proof copy approval processes and interactions with Printed Packaging Development.
- Liaise closely with GRA International Scientist and Manufacturing/supply chain on the creation of new MML/CS to support product launch.
- Manage ARF and Truth/Proof Process including, if applicable, any needed translations to create new and updated MML/CS and provide required submission documents to affiliate ALRPs, or support external Business Alliance Partner with appropriate documentation to develop the MML/CS Truth Copy, provide additional submission documents and coordinate the ARF and Truth/Proof Process.
- Drive the maintenance of marketed product MML/CS in line with reference label, internal timelines and bundling decisions.
- Monitor, support and drive the implementation of updated or new labelling components into the market.
- Maintain the MML strategic plan.
- Monitor reference country product labels for planned implementation.
- Maintain up-to-date knowledge of submission statuses, requirements, and conditions of markets.
- Network with global manufacturing site functions such as Supply Chain, Manufacturing, Regulatory, external Alliance Business Partners and Printing, Packaging and Development to develop/coordinate the development of labelling materials, acquire submission documents and plan and manage MML production decisions.
- Create SAIL/RIM entries when needed for each impacted market for plann
