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.

In this role you will be responsible for:

• Proposing regulatory strategy with regard to Chemistry Manufacturing and Control (CMC) for assigned products in close cooperation with the relevant global, regional, and country RA functions.
• Ensuring early identification of major regulatory hurdles and issues with regard to CMC related topics, regulatory guidelines and legal requirements, and coordination of respective corrective actions.
• Timely availability and final content approval of CMC documents for assigned products to necessary Authorities, including responses to authority questions.
• CMC change management for assigned development and marketed products, which includes tracking of CMC changes and processing of requests for related documentation.
• Coordination of responses to health authority questions, and for implementation of CMC changes after approvals with product supply and contract manufacturers, to ensure regulatory CMC compliance.
• Proposing regulatory strategy with regard to Chemistry Manufacturing and Control (CMC) for assigned products in close cooperation with the relevant global, regional, and country RA functions.
• Ensuring early identification of major regulatory hurdles and issues with regard to CMC related topics, regulatory guidelines and legal requirements, and coordination of respective corrective actions.
• Timely availability and final content approval of CMC documents for assigned products to necessary Authorities, including responses to authority questions.
• CMC change management for assigned development and marketed products, which includes tracking of CMC changes and processing of requests for related documentation.
• Coordination of responses to health authority questions, and for implementation of CMC changes after approvals with product supply and contract manufacturers, to ensure regulatory CMC compliance.

Main tasks include:

• Coordinate and/or prepare regulatory CMC documents (IND/IMPD and for MAA/NDA).
• Sign off documents as content approver for general sections.
• Perform regulatory maintenance of the CMC section throughout the life cycle of the product(s).
• Coordinate and/or prepare regulatory the CMC responses during regulatory IND/IMPD/ NDA/ MAA assessments.
• Communicate CMC regulatory status to the Technical Development Project Teams (TDTs), Bayer AS QPs and Contract Manufacturing Organizations (CMOs).
• Responsibility for identifying regulatory consequences of CMC changes for assigned development and marketed products, change control of technical regulatory documents (TRDs), and for communicating regulatory approvals, commitments, and conditions to internal and external stakeholders to ensure regulatory CMC compliance.
• Review and interpret relevant CMC regulations and guidelines, communicate and advice within Bayer AS or CMOs as appropriate.
• To prepare and maintain relevant CMC Documentation SOPs

Qualifications and experience

You have a Masters degree in a pharmaceutical science (Pharmacy, Biochemistry, Chemistry) and 2-3 years experience in working with regulatory documentation and quality assurance in a pharmaceutical or biotech environment. A reduced level of formal education can be compensated for by longer experience.

You are a proactive person who likes to work in project teams, solving complex problems in a structured manner. Interaction and communication with stakeholders both within and outside the Bayer organization will be part of your daily activities. You thrive when faced with challenges which must be solved in an evidence-based manner, quickly, and with high quality. At Bayer Dynamic Shared Ownership is central to the way we work, and the individual is empowered and accountable to drive progress in the interest of the patient.

Questions

If you want to know more about this position, please contact Daniel Lawton at daniel.lawton@bayer.com or phone +47 48315929.

How to apply

Do you find this role as an exciting opportunity? We are reviewing applications on an ongoing basis, latest date for application and relevant documentation is June 9th 2025.

Position is temporary from November 1st 2025-September 30th 2026.

Functional area: Product Supply, QA Radiopharmaceuticals
Seniority level: Professional

#LI-NOR