Regulatory Affairs Manager BeNeLux & RA Label Compliance Manager EU/Global

Hiring Manager: van de Wiel Mirjam 

If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In Research & Development, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the live of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.

What the job looks like
Each day, you’ll enjoy a variety of challenges such as:

50% Regulatory Affairs (BeNeLux): 
Manage the regulatory activities for licenses in the BeNelux in accordance with the European and national requirements and Grünenthal (GRT) standards.

• Manage Marketing Authorizations and ensure marketed products fulfill all requirements:
  • Perform local regulatory activities to obtain marketing authorizations for pharmaceutical products, and maintain the MA by submitting the required variations. (Most products are registered via MRP/DCP or via national procedures, some via CP.) 
  • Arrange transfer and launch of newly acquired products.
  • Manage and check local translations of SmPC, package insert and labelling in national languages. 
  • Interact with local authorities and headquarters to support product approval and compliance and ensure that enquiries from local authorities are handled in a serious and timely manner.
  • Initiate, check and approve artwork changes and ensure timely implementation.
  • Create/translate and implement additional Risk Minimization Measures (e.g. educational material) if applicable.
  • Ensure submission of all notifications in compliance with local legislation and guidelines.
• Internal processes and support:
  • Provide updated realistic timelines to the local organization for the approval and availability of new products and relevant changes of existing products (e.g. new indications, line extensions, reformulations). 
  • Ensure that updated local legislation and guidelines are available and interpreted for the use of project teams and other relevant GRT employees (both locally and in HQ).
  • Be aware of and highlight regulatory opportunities and identify issues and problems, and recommend solutions through the reporting lines.
  • Provide input to the strategic review of product portfolio at GRT in close association with the cross-functional teams.
  • Ensure that relevant processes are described in SOPs or other structured documents, and reviewed and updated accordingly.
  • Ensure that an overview of the registration status for all products is maintained in the BeNeLux, including the tracking of all submissions and commitments.
• Review of promotional and non-promotional materials
  • Ensure compliance of promotional and non-promotional materials with local pharma codes. Interact with marketing and medical to support creation of compliant materials. 
• Clinical trials:
  • Submit clinical trial applications and amendments, and follow-up evaluation and answers to the questions of the competent authority.
     

50% Regulatory Affairs Label Compliance (EU/Global):

Support Regulatory Affairs procedures in place to comply to the Global Label Management Process ensuring worldwide / regional consistency and governance

• Provide functional support to maintain and develop regulatory labeling-related systems, processes and compliance activities.
• Routinely support the RA Compliance Lead / Labeling in the process of providing end-to-end (E2E) oversight of the Global Label Process to the Global Label Management Board (GLMB) with data continuity and tracking across all functions involved (e.g. Development, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Artwork, Supply Chain and Quality) 
• Support and manage the process of escalation of labeling issues (e.g. delays in timeline, content deviations) to the GLMB according to the Global Label Process. This includes reporting to the GLMB secretary safety relevant information on the Global Label Process performance deviations.
• Ensure the LMB secretary role for all core and non-core products and the setting up of the meeting calendar, documentation and archiving as well as functional support.
• Maintain in-depth knowledge of relevant SOPs, laws, regulations and guidelines relevant to regulatory labeling and cross functional projects that impact compliance.
• Support the cross functional projects that impact label compliance.
• Partner with affiliates to promote local compliance with labeling policies and standards supporting in the review of local process/standard procedural documents, describing the processes followed locally or reference to use of global procedures, in accordance with local regulations and in alignment with GRT Group procedures, as required.
• Support Global Label Process training in GRT.
• Support appropriate filing and archiving of the Global Label Process-related documentation.
• Support regulatory audits and inspections as required.
• Accountable: 
  • Metrics and measures in place to monitor quality and compliance of all critical steps in the Global Label Process from trigger to approval.
  • Oversight of the regulatory labeling compliance, as assigned/defined. 
  • Encourage continuous improvement through capture of learnings and develop, maintain and implement plans and process to handle and respond to change management needs within regulatory compliance.
     

What you‘ll bring to the table
To make the most of this role and truly thrive, you should have:

• Relevant experience in Regulatory Affairs within the pharmaceutical industry or competent authority, including labeling activities.
• University degree in Life Science (pharmacy, medicine, biomedical sciences or equivalent discipline)
• Languages: fluent French, Dutch and Business English
• Microsoft based and general IT competence
• Ability to work in an international environment with a multiplicity of stakeholders  
• Ability to work on multiple tasks simultaneously and focus on details, as well as holding a high level overview
• Structured and attention-to-detail working style
• Flexible, independent, proactive and open working style 
• Strong communication, negotiation and problem solving skills
• Good analytical spirit and team-player

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"In this role you will be working 50% in the local affiliate to perform regulatory activities for the BeNeLux and working 50% for Global Regulatory Affairs to support worldwide / regional consistency and governance of labelling activities. Join our team and become part of the GRT family" van de Wiel Mirjam, the Hiring Manager