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Regulatory Affairs Manager (m/f/d)
The Pharmaceutical Division of Bayer S.p.A. is looking for a motivated and experienced Regulatory Affairs Manager. He/she will contribute to the EU regulatory strategies aligned with national business objectives, ensuring compliance and supporting new product launches and lifecycle management across Pharma and Radiology. The role includes anticipating legislative changes, driving regulatory intelligence and improvement initiatives, and contributing to EU Regulatory Affairs with cross‑functional input and representation in scientific associations.
YOUR MAIN TASKS AND RESPONSIBILITIES:

Contribution to EU regulatory strategy for development and lifecycle management
Critical evaluation and interpretation of complex technical data across assigned therapeutic areas — including pre‑clinical, clinical, pharmacovigilance, and CMC — to ensure alignment with regulatory requirements, business objectives, and global strategies
Preparation of the local regulatory environment for launch, including trend analysis, competitor intelligence, and scenario planning
Support to EU Regulatory Affairs for fast approvals and optimal labeling tailored to local access needs and leading Health Authority interactions as needed
Regulatory lead within launch teams, managing all activities related to product launch and support Price & Reimbursement (P&R)
Development of regulatory strategies to support reimbursement negotiations and inform on legislative impacts, risks, and opportunities within cross‑functional teams
Ensuring compliance of commercial operations with national legislation and advising on regulatory implications for business
Proactively identifying regulatory risks due to evolving local laws and being part of issue management

WHO YOU ARE:

Master’s Degree in a Scientific discipline or related fields
Postgraduate master’s in Regulatory affairs will be considered a plus
At least 5 years of previous experience in Regulatory Affairs within the pharmaceutical industry
Strong regulatory knowledge of both Italian and EU legislation, with good understanding of Market Access dynamics and commercial needs
Experience in Regulatory Affairs activities for medical devices will be considered a plus
Flexible, agile, and digitally minded, with a positive attitude toward change and a strong willingness to learn and innovate
Residence or domicile in Lombardia is preferred
Fluent knowledge of English and Italian mother tongue

Location: MilanType of contract: Permanent
Application Period: 03.12.2025 – 17.12.2025Reference Code: 855456
Contact Us:Viale Certosa 130, 20156 MilanoHROP_Italy@bayer.com
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