Labeling Strategist, Manager, Regulatory Affairs Europe (Lake County, IL based)

Employer
AbbVie
Location
Lake County, IL, US
Posted
Oct 30, 2018
Ref
1807395
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

This individual is expected to provide support to the European Regulatory Affairs labeling group (based from Lake County, IL) 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 as well as coordinate labeling for Centralized Products and products approved through the Mutual Recognition Procedure and directions for implementation. This person will support the WE/EU labeling representatives and Area Leads on relevant project teams and interface with the Global Label Management (GLM) and Label Control Center (LCC) functions in Operations QA.

Job Responsibilities

  • Under the direction of the Associate Director of Labeling, provide advice and counsel on EU labeling impact/requirements during discussions and concepts during early stage product development. May propose draft labeling text (content) during these discussions and draft pack content/layout.
  • Responsible for ensuring compliance with the SmPC and other labeling requirements for Summary of Product Characteristics (SmPC) and related patient insert and labeling (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 materials, author documents, meet submission timelines for assigned products including rapid response label/PI authoring and/or review on EU time zone.
  • 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, label center, GLM and other functions as required based on submission timelines (under the direction of the Associate Director of Labeling).
  • 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.
  • Open mock up Master Change Requests (MCRs) for EU, for production artwork describe and communicate content and agreed agency timelines of changes to affiliates and 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 (EU time zone).
  • Support mock-up generation, including review of draft documents, providing regulatory labeling comments, interpreting comments from agency on mock-ups and specimens, under direction from the Associate Director of Labeling. 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 or support project work related to labeling improvements or compliance such as house-style, or QC/Label review, under the direction of the Associate Director of Labeling.
  • Attend CHMP meetings as the Labeling lead at the time of product approval or pre-submission meetings, under the direction of the Associate Director of Labeling.
  • Support inspection readiness activities and label reviews for assigned products under the direction of the Associate Director of Labeling.
  • Lead readability testing strategy for assigned products - including drafting bridge tests when needed.


Proposed product/project responsibilities:

  • Marketed products including Viekirax, Exviera, Maviret and Synagis.
  • Support development products as appropriate, under direction of the Associate Director of Labeling.
  • Lead review of assigned products for the label review project.
  • Lead MDR impact assessment for the team.


Basic:

  • 5-7 years in Regulatory, R&D or related area, 3 years in Regulatory preferred with 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).
  • 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.


Education
  • Bachelor's degree in Pharmacy, Biology, Chemistry, Pharmacology or related subject. Advanced degree preferred.