Labelling Strategist Manager, Regulatory Affairs, Europe
Labelling Strategist Manager, Regulatory Affairs, Europe
AbbVie
Maidenhead, United Kingdom
Role overview:
The Labelling Strategist Manager is expected to take responsibility to develop and maintain end to end product labelling on behalf of the SGL (Strategic Global Labelling) Europe and will be responsible for actively contributing to the development and implementation of the European Union regulatory labeling strategy and documentation for marketed products and products in development. Working on Centralised Products and products approved through the Mutual Recognition Procedure. In this role you will represent the SGL EU team for content at cross functional Labeling Strategy teams as well as with Operations colleagues for packaging artwork and implementation and work closely with Regulatory colleagues throughout the EU and beyond.
Key Responsibilities:
- Provide advice and counsel on EU labeling impact/requirements during discussions and concepts during early-stage product development.
- Propose draft labeling text (content) during these discussions and draft pack content/layout.
- Lead assigned products for the team.
- Responsible for ensuring compliance with the EU labeling.
- Review/QC materials, author documents, meet submission timelines for assigned products including rapid response label/PI authoring and/or review.
- Analyse competitor labeling.
- Agree timelines for submission and implementation of label changes.
- Maintain active awareness of all relevant EU legislation and guidance relevant to EU product information/ labeling and assess impact on AbbVie business and R & D programs, in collaboration with RPI.
- Support mock-up generation, including review of draft documents, providing regulatory labeling comments, interpreting comments from agency on mock-ups and specimens. This individual will also be responsible for drafting responses to QRD or mock-up and specimen comments with the relevant Area RA Product Strategist and direct contact with QRD as appropriate.
- Lead or support project work related to labelling improvements, compliance, or systems.
- Support inspection readiness activities & Label reviews for assigned products.
- Lead readability testing strategy for assigned products – including drafting bridge tests when needed and vendor management where required.
- Take responsibility for epi website build and maintenance for assigned products where applicable.
- Project manage linguistic review procedures for assigned products and translations with central vendors and/or instruct other team members to work on the linguistic review for your products.
- Manage the product information in the RIM system, including routing and approvals.
- Author other module 1.3.1 documents as required for assigned products.
Qualifications:
- Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology or related subject. Advanced degree preferred.
- Significant number of years’ experience in EU Regulatory, R&D or related area; preference for regulatory affairs and regulatory labeling experience, equivalent experience within the pharmaceutical industry also considered.
- A solid working knowledge of drug development process with EU/CP .
- Strong project management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (both written and oral) required as well as strong team mindset.
- Competent knowledge of and demonstrated ability to apply EU regulatory guidelines pertaining to product labeling. Must be able to work independently and be flexible with meetings on different time zones at both ends of the working day.
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