(based in UK or remote in an EU office)
This individual is expected to take responsibility to lead development and maintenance for end to end product labeling on behalf of the SGL EU labeling group 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 with minimal input from management. Working on Centralised Products and products approved through the Mutual Recognition Procedure. This person will represent the SGL EU team for content at Labeling Sub Teams as well as with Operations colleagues for packaging artwork and implementation and work closely with Regulatory colleagues throughout the EU. In addition, the Senior Manager will be responsible for line managing more junior members of the team and training less experienced staff in a matrix environment.
- 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.
- Responsible for ensuring compliance with the SmPC & other labeling requirements for Summary of Product Characteristics (SmPC) and related patient insert and labelling (PI Annex I-III) for pharmaceutical products in Europe for assigned products.
- Ensure alignment of overall key labeling statements and key messages across EU labeling documents for assigned products.
- Ensure consistency of EU labeling across assigned product lines and compliance with AbbVie policies and procedures.
- Review/QC materials, author documents, meet submission timelines for assigned products including rapid response label/PI authoring and/or review.
- In collaboration with other Global Labeling team members, analyze competitor labeling for products in same class to ensure AbbVie products have most competitive labeling. Maintain awareness of recent competitor approvals in class/region for assigned products.
- Agree timelines for submission and implementation of label changes through interface with RA Area product owners, Brand managers, supply chain, Global Label Management and other functions as required based on submission timelines).
- 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.
- Provide information for artwork briefs for EU, for production artwork describe and communicate content and agreed agency timelines of changes to affiliates & GLM, provide master mock-ups/word documents to enable redlining in the EU. Present updates/forecasts to affiliates/LCC and other stakeholders at regular (bi-weekly) affiliate meetings for assigned products.
- Lead 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
- Collaborate with product WE team, Brand Manager, GLM and others to build launch plans/schedule for artwork and labels for assigned products.
- Lead project work related to labelling improvements or compliance or systems.
- Attend CHMP meetings as the Labeling lead at the time of product approval or pre-submission meeting.
- 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 and reviewing those of direct reports.
- Take responsibility for epi website design, build, agency submission/approval and maintenance for assigned products where applicable.
- Project manage linguistic review procedures for assigned products and translations with central vendors or assign work and manage completion by direct reports or other team members.
- Manager the product information in the global labeling system, including routing QC and approvals.
- Author other module 1.3.1 documents as required for assigned products.
- Line management of more junior team members and supervision of their products, act as back-up for those products and help with workload and training.
- Support for other products during absence as needed.
- Maintain awareness of external labeling trends and actively engage in external discussions on behalf of the team.
Proposed product/project responsibilities:
- Product responsibility for marketed and development products assigned to the role.
- Manage other team members in review/approval/MAA activities.
Bachelor degree in Pharmacy, Biology, Chemistry, Pharmacology or related subject. Advanced degree preferred.
Regulatory, R&D or related area - Regulatory experience required with preferred experience in regulatory affairs labeling or equivalent experience within the pharmaceutical industry, European experience required.
A solid working knowledge of drug development process with EU/CP experience is highly desirable. Candidates must be able to demonstrate strong project management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (both written and oral) and line management experience. 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.
Travel: Yes, 10 % of the Time
Job Type: Experienced