Regulatory Affairs Manager

Regulatory Affairs Manager – Benelux region

Join Bayer Pharmaceuticals and take a pivotal role in shaping the future of our medicinal products in the Benelux region. You will lead regulatory affairs activities and projects while providing market access support to ensure products achieve and maintain regulatory approvals and patient access.

• Deliver Regulatory Milestones
  • Act as a trusted partner to local health authorities and foster strong relationships with regulators, policymakers, and industry leaders.
  • Join response teams to tackle urgent regulatory matters and bring expertise to the forefront.
  • Collaborate across the organization to drive optimal outcomes for all stakeholders.
• Ensure Local Regulatory Compliance
  • Manage the timely and high‑quality submission of critical documentation.
  • Monitor submission status and craft responses to authority requests, ensuring proper documentation and compliance.
  • Implement approved labelling and CMC changes into the product portfolio and support promotion towards patient availability.
  • Maintain transparent communication with local authorities and keep team members updated on legislation, legal framework, and market dynamics.
  • Contribute to building strategies that align regulatory and commercial goals, paving the way for successful product launches.
• Provide Support for Market Access Projects
  • Collaborate closely with the Market Access department within the Benelux context and engage in a diverse array of market access activities.
  • Interact with external stakeholders, including health authorities and industry associations, to ensure compliance and foster collaboration.
  • Work with local teams in marketing, medical, and market access to align strategies and objectives.
  • Coordinate with global regulatory affairs teams to support overarching goals and initiatives.

• University degree or equivalent in pharmacy, chemistry, biological sciences, or medicine.
• Experience successfully managing registration projects and active participation in regulatory authority meetings or professional organisations.
• Fluency in English and Dutch.
• Strong communication, negotiation, and presentation skills.
• Project management capabilities.
• High degree of accuracy and reliability.

• Gross monthly salary between €4,823 and €6,029 based on a 40‑hour workweek, depending on education and experience.
• Additional 8% holiday allowance, year‑end premium, and a bonus based on company results.
• 34 days of leave.
• Flexible work arrangement: option to work from home with a minimum of two office days per week, and a monthly internet allowance.
• Solid retirement plan and bicycle lease plan.
• Inspiring working environment with professional and committed colleagues.
• International career possibilities and continuous learning opportunities.
• Employee assistance program and free access to an in‑house gym, including weekly group workouts.

Netherlands – Hoofddorp, Benelux Region.

Reference Code: 867644