Regulatory Affairs Manager

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Within Bayer, we're changing the way we work— for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here https://www.bayer.com/en/strategy/strategy

Regulatory Affairs Manager

Are you ready to take on a pivotal role in shaping the future of Bayer Pharmaceuticals in the Benelux region? Within our combined Regulatory Affairs & Market Access department, we are looking for a passionate, dedicated Regulatory Affairs Manager to lead regulatory affairs activities and projects, while also providing market access support. This is not just a job; it’s an opportunity to make a significant impact by ensuring that our medicinal products achieve and maintain regulatory approval while reassuring access to 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 our product portfolio and support the 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 frame 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 RA and Market Access departments collaborate closely within the Benelux context, providing you the opportunity to engage in a diverse array of market access activities.

In this role, you'll 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 our overarching goals and initiatives.

Patients first! 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 the areas of 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. Are you just as committed, focused and passionate as we are about shaping the future of health care?

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  Project Management skills
• High degree of accuracy and reliability

WHAT BAYER OFFERS YOU

As a modern employer, we take care of our employees and help them find a balance between career development opportunities and personal life planning. We offer our employees a wide range of career prospects, a modern working environment and competitive compensation. Bayer employees benefit from great employment conditions, such as:

• A gross monthly salary between €4823 and €6029 based on a 40-hour workweek, depending on your education and work experience

• An additional 8% holiday allowance, year-end premium, and a bonus (based on company results)

• 34 days of leave

• You have the option to work from home, but we expect you 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 to develop

• At Bayer, we value your well-being. We offer support via our employee assistance program and provide various tools and initiatives to enhance your well-being including free access to our in-house gym and participation in weekly group workouts.

Be innovative, be Bayer. We shape the future of everyday health, patient care and agriculture. Together, we can advance health and nutrition for all. Guided by our purpose ‘science for a better life’, rooted in our DSO approach and steered by the organization’s strategy, we reach for our ambitious vision. Help bring this vision to life: ‘Health for all, hunger for none’.

INTERESTED IN THIS VACANCY?

Are you looking for a new challenge? Apply online by sending us your resume and cover letter (in 1 document). Do you have a question or do you want to learn more about the position? You can always contact Katrien Mertens via 0032 495 541019 or Katrien.mertens.ext@bayer.com.

What can you expect? The application process consists of a phone screening, a personality questionnaire and reasoning test and an interview with the recruiter and hiring manager.

Would you like to know more about what our people do and how they feel at Bayer? Check https://www.bayer.com/en/nl/career/our-people#489796 and follow us via #TeamBayerBenelux!

We do not accept any unsolicited applications via agencies.

#LI-BNL

YOUR APPLICATION

Do you want to work in a place where you can be just YOU? Your unique personality, background and talents help build a strong, diverse and inclusive Bayer. So join us! Be You, Be Bayer.

Location:

Netherlands : Netherlands : Hoofddorp

Division:

Pharmaceuticals

Reference Code:

867644