Head of Regulatory Affairs

Head of Regulatory Affairs

AbbVie

Wavre, Belgium

The Head of Regulatory Affairs provides regulatory vision and leadership to the Affiliate. S/he executes these responsibilities by utilizing experience, knowledge of regulatory landscape, passion and creativity to provide patient-centric and compliant regulatory expertise in line with AbbVie’s vision. S/he supports the best interests of patients, the Affiliate and AbbVie within the country with regard to interactions with the regulatory agency and other regulatory authorities. Within AbbVie s/he represents the country to the wider organization throughout the product lifecycle. S/he contributes to the affiliate's overall success by developing objectives, strategies and tactics in line with business goals and culture. S/he is an active participant in the business life of the affiliate leading and supporting affiliate initiatives.

Overall responsibilities

  • As member of the affiliate management team collaborates actively to create a vision, strategy and objectives for the company’s product portfolio (medicines and devices) and initiatives, and transmits the vision and objectives to the affiliate regulatory department;
  • Supports the business of the company including involvement in planning for and execution of product launches, acquisitions and divestitures;
  • Develops and manages the RA department to ensure optimal function of the department, development of strategic and tactical plans and execution;
  • Supports the affiliate regulatory team to:
    • Work with the affiliate brand teams to provide regulatory information on affiliate products and to develop strategies, objectives, tactics and timelines for those products throughout their lifecycle;
    • Work with the area regulatory team to advocate for the affiliate's strategy objectives and timelines;
    • Work with local regulatory authorities to obtain optimal outcomes for patients and Abbvie’s portfolio.
  • Is present in the country regulatory environment including interactions with regulatory policy makers and professional associations in order to gather knowledge about trends, future changes and current landscape in accordance with the national and EU legislation and relevant Associations’ Codes;
  • Collaborates with other functions of the Management Team to ensure consistency in vision, strategy, tactics and communication with external agencies and stakeholders;
  • Ensures compliance within the RA department and collaborates with pharmacovigilance and other stakeholders, as appropriate, to ensure compliance with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie;
  • Responsibility for the Belgium/Luxembourg Regulatory budget.

Main Accountabilities

  • Development and execution of regulatory strategy, tactics and timelines;
  • Communication and collaboration with the Affiliate Management Team, Regulatory Area, and other teams and functions relevant;
  • Participation in affiliate and function budget, long range plan and LRP exercises, monitor and update budget and manage resources in compliance with the budget and planning exercises;
  • Overall responsibility for affiliate RA compliance with focus on (but not limited to):
    • Ensure adequate staff qualification and training;
    • Act as primary point of regulatory contact for audits and inspections in Belgium, if appropriate;
    • Ensure submission and content of new Marketing Authorisations, variations and other regulatory submissions, including label, artwork and local prescribing information. Acts as variations officer (see separate function description).
  • Functions as a subject matter expert both within regulatory advertising and promotion and related functional areas;
  • Review of promotional and non-promotional materials in accordance with legislation, local procedures and codes of practice;
  • Cover Regulatory aspects related to Pharmacovigilance (e.g. DSUR submissions, Direct Healthcare Professional Communication);
  • Ensures appropriate and timely communication of regulatory and safety information within the regulatory department, to pharmacovigilance and other internal stakeholders, as well as to the regulatory authorities, as required by local regulation, company policies and procedures;
  • Ensures execution of regulatory responsibilities with regards to affiliate vision and strategy aimed at influencing legal/healthcare policies and political developments;
  • Oversees the analysis of evolution of Belgium, Luxembourg and European pharmaceutical law and its consequences for the company’s business;
  • Provides effective resolution of regulatory issues occurring within the Belgium/Luxembourg affiliate, with an appreciation of business needs and priorities;
  • Liaises with Corporate groups, including European Regulatory Affairs, Global Regulatory Affairs, Market Access, Medical, and Patient Relations.

Required Education/Knowledge/Experience

  • Strong Visionary, strategic, tactical and motivational skills;
  • Strong negotiation, influencing, presentation skills;
  • Highly developed people and project management skills;
  • Consultative and collaborative interpersonal style;
  • Life Sciences Degree (e.g. Pharmacy);
  • Advanced experience within regulatory affairs;
  • Strong understanding of the healthcare industry;
  • Excellent Dutch, French and English language skills.

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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