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MSD Global Excellence Lead Regulatory Affairs 
Netherlands, North Brabant 
693553203

08.09.2024

Job Description

Key role in driving the advancement of Global Regulatory Affairs

Purpose of the role

Reporting into the Executive Director GRA, and as part of the GRA Leadership Team, you are responsible for implementing mature portfolio and project management practices, enhancing collaboration and promoting the sharing of best practices. You will oversee the GRA Excellence team (3 employees) and lead the management of global compliance and regulatory projects, ensuring high standards in project execution, planning, resource allocation, budgeting and stakeholder communication. Your responsibilities also include overseeing the project portfolio and prioritization and drive towards a comprehensive regulatory intelligence database. Leveraging your expertise, you will lead continuous improvements in both internal and external processes, streamline regulatory document management, and contribute to broader GRA initiatives. Additionally, you will support the Regulatory Strategy Team in managing priority projects, collaborate with cross-functional teams (e.g., R&D, Manufacturing, Quality, and Science & Technology), and expertly navigate regulatory frameworks, particularly in non-EU/US markets.

Your profile

  • Academic degree in biomedical Sciences (e.g., virology, bacteriology, molecular biology, veterinary sciences).
  • Extensive and relevant experience in the (veterinary) pharmaceutical industry in the development and/or maintenance of products, and in regulatory affairs, preferably in the field of biologicals.
  • Excellent project- and change management skills & proven ability to manage challenging projects in a complex matrix organization.
  • Strong problem-solving and decision-making abilities.
  • Ability to think Out-of-the-Box and challenge status quo with a continuous improvement mindset.
  • Excellent command of the English language.

What we offer

A new position with impact, offering the opportunity to contribute to our success as this new team will facilitate cross-functional alignment, enhance collaboration, and align with our dedication and commitment to Excellence. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

  • Competitive salary.
  • 25 days of leave.
  • Company car.
  • Bonus Plan subject to the company annual results.
  • Incentive Plan.
  • Solid Pension Plan.

For questions about this vacancy

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10/04/2024


A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.