Regulatory Affairs - Business Excellence Portal 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.

As part of our Global Regulatory Affairs – Business Excellence organization, you play a key role in managing Health Authority submission portals worldwide. Your main focus lies in ensuring compliant, efficient, and high-quality handling of Clinical Trial Applications (CTAs) within CTIS and other regulatory systems.

YOUR TASKS AND RESPONSIBILITIES

• You are responsible for managing the CTIS Portal for centralized CTAs under EU-CTR
• You coordinate, prepare, and submit EU CTAs and all associated lifecycle activities (e.g., amendments, Annual Safety Reports, End-of-Trial notifications, CSRs) while collaborating closely with clinical, regulatory, and external stakeholders
• You ensure daily operational oversight of CTIS and act as the primary interface to approximately 30 national EU Health Authorities on behalf of the sponsor
• You retrieve, analyze, interpret, and manage regulatory and clinical data, assess data relevance, and ensure high-quality entries in Health Authority databases
• You identify emerging issues, assess their impact on milestones, prepare mitigation strategies, and proactively inform stakeholders such as GRT and EU PTSD
• You resolve technical or procedural challenges in direct interaction with Health Authorities and EMA Support, providing case-based solutions beyond standard processes
• You continuously evaluate and optimize systems, processes, and workflows related to submission portals, including system developments (e.g. Veeva Vaults and opportunities for further automation)
• You act as a subject matter expert, serving as the technical go-to person and supporting audits and inspections related to regulatory submission portals

• You hold a degree in biomedical life sciences or a comparable field
• You have several years of experience in the healthcare or pharmaceutical industry (e.g., Research, Regulatory Affairs, Product Development, Production, Quality Assurance)
• You are skilled in working with regulatory submission systems and understand operational requirements of CTAs under EU-CTR
• You are experienced in analyzing complex data and assessing regulatory relevance
• You bring strong knowledge of global regulatory processes and digital submission platforms
• Soft skills such as problem-solving, structured communication, and cross-functional collaboration describe you
• Fluent English (written and spoken) rounds off your profile

The role is to be filled from 1st April 2026 for a fixed-term duration of 15 months.

The possibility to work remotely from EU countries can be individually discussed.

Our benefits package is flexible, appreciative, and tailored to your lifestyle, because:
What matters to you, matters to us!

• We ensure your financial stability through a competitive compensation package, consisting of an attractive base pay and our annual bonus. In addition, managers can recognize special contributions by granting an individual performance award or top performance award.
• Whether it’s hybrid work models or part-time arrangements:
  Whenever it is possible, you will have the flexibility to work how, when and where it is best for you.
• Your family is a top priority. We offer loving company daycare centers at multiple locations, support in finding childcare, time off for the care of elderly or dependent family members, summer camps for children, and much more.
• We support your professional growth by providing access to learning and development opportunities, training programs through the Bayer Learning Academy, development dialogues, as well as coaching and mentoring programs.
• We promote health awareness and opportunities for selfcare through various measures, such as free health checks with the company doctor.
• We embrace diversity by providing an inclusive work environment in which you are welcomed, supported, and encouraged to bring your whole self to work.

Be You. Be Bayer.

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Regulatory Affairs Business Excellence Portal Manager all genders
• Wuppertal-Aprath, North Rhine Westfalia, DE