Regulatory Affairs Manager

At Bayer, we are looking for a passionate, dedicated Regulatory Affairs Manager to lead regulatory affairs activities and projects within the combined Regulatory Affairs & Market Access department in the Benelux region, while also providing market access support.

Are you ready to take on a pivotal role in shaping the future of Bayer Pharmaceuticals in the Benelux region? This is an opportunity to make a significant impact by ensuring that medicinal products achieve and maintain regulatory approval while supporting access for patients.

YOUR TASKS AND RESPONSIBILITIES

In this vital position, you will:

1. Deliver Regulatory Milestones

• Act as a trusted partner to local health authorities, fostering strong relationships with regulators, policymakers, and industry leaders.
• Join response teams to tackle urgent regulatory matters, bringing your expertise to the forefront.
• Collaborate strongly and effectively within the organization to drive towards the best outcomes for all stakeholders.

2. Ensure Local Regulatory Compliance

• Manage the timely and high-quality submission of critical documentation.
• Keep a close eye on submission statuses and assist in crafting responses to authority requests, while ensuring proper documentation and compliance.
• Implement approved labelling and CMC changes into the product portfolio and support promotion towards availability for patients.
• Maintain open and transparent communication with local authorities while keeping yourself and team members up to date on legislation, legal framework, and market dynamics.
• Contribute to building strategies that align regulatory and commercial goals, paving the way for successful product launches.

3. Provide support for market access projects

• The Regulatory Affairs and Market Access departments collaborate closely within the Benelux context, providing the opportunity to engage in a diverse array of market access activities.

In this role, you will engage with external stakeholders, including health authorities and industry associations, to ensure compliance and foster collaboration. Internally, you will closely collaborate with local teams in marketing, medical, and market access to align strategies and objectives. You will also interact with global regulatory affairs teams, supporting overarching goals and initiatives.

At Bayer Pharmaceuticals, we are passionate about shaping the future of patient care. By focusing on prescription products in cardiology and women’s health, we propose new treatments for cardiovascular diseases and drive innovation for women. By concentrating on specialty therapeutics in oncology, hematology, and ophthalmology, we fight cancer, treat hemophilia, and protect vision. Our mission is to research, develop, manufacture, and market specialized products that improve the health of people throughout the world.

WHO YOU ARE

• University degree or equivalent in pharmacy, chemistry, biological sciences, or medicine.
• Some experience in successfully managing registration projects.
• Active participation in meetings organised by regulatory authorities and professional organisations, national or regional.
• Fluent in English and Dutch.
• Ability to communicate effectively, with proven negotiating skills, convincing presentation skills, and project management skills.
• High degree of accuracy and reliability.

WHAT BAYER OFFERS YOU

As a modern employer, Bayer supports employees in balancing career development opportunities and personal life planning. Employees benefit from great employment conditions, such as:

• An additional 8% holiday allowance, year-end premium, and a bonus based on company results.
• 34 days of leave.
• The option to work from home, with an expectation of at least 2 days per week at the office.
• If you work from home, Bayer provides the required tools and a monthly internet allowance.
• A solid retirement plan and bicycle lease plan.
• An inspiring working environment with professional and committed colleagues.
• A successful innovative organization with international career possibilities.
• Challenges and possibilities to learn and develop.
• Support via an employee assistance program and various tools and initiatives to enhance well-being, including free access to the in-house gym and participation in weekly group workouts.