The Role:The Global Labeling Operations Manager/Associate Director is responsible for the regulatory role as part of the process for coordination, development and implementation of new...
The Global Labeling Operations Manager/Associate Director is responsible for the regulatory role as part of the process for coordination, development and implementation of new and revised printed labeling for assigned commercial products. Coordinate and/or leadlead packaging component labeling content development and support the labeling content development of USPIs and other regional labeling.
- Point of contact for Regulatory Affairs towards the process for the creation, approval, and implementation of commercial printed labeling in collaboration with various functions.
- Manage labeling submissions for US and EU, including QC, proofing, copy editing and formatting of documents, and coordinate review and approval of final submission.
- To provide tactical and strategic guidance to product labeling teams regarding placement and regulatory requirements for regional packaging component labeling content and design.
- Coordinates and/or leads cross-functional teams in the development and lifetime maintenance of the US, EU and other regional packaging component labeling for all commercial products.
- Understand industry labeling trends related to packaging and labeling implementation, reviewing competitor and other labelling.
- Interpret regional labeling regulations and guidance, determining company impact and providing comments as appropriate.
- Contribute the regulatory labeling perspective in support of novel packaging design initiatives
- Ensure proper version control and document integrity of packaging component labeling, printed labeling artworks and other assigned labeling documents.
- Originate precedent searches, create and maintain labeling comparisons, and assist in analysis of competitive labelling.
- Interact with Marketing Company colleagues regarding global artworks as appropriate.
- Oversee EU translations process as appropriate.
- Coordinate Content of Labeling/Drug Listing SPL generation and review.
- Draft summaries of relevant labeling changes for PSURs, Annual Reports and other periodic reports
- Maintain labeling history documents and assist in responding to labeling-related queries from various functional areas.
- Maintain repository of current labeling documents, including appropriate website repositories.
- Process and prepare all US Final Printed Labeling and required EU specimens for submission.
Degree in Life Sciences required.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.