Regulatory Affairs Manager
3 giorni fa
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.
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: Milan
Type of contract: Permanent
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