Regulatory Affairs Manager (m/f/d)

Bayer CropScience Limited; Milano; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A global pharmaceutical company is seeking a Regulatory Affairs Manager to contribute to EU regulatory strategies and ensure compliance for new product launches. The successful candidate will evaluate complex technical data, manage regulatory activities, and support reimbursement negotiations. A Master's in a scientific discipline and 5 years of experience in regulatory affairs in the pharmaceutical sector are required. Fluent English and Italian are essential, and preference is given to candidates residing in Lombardia.

Competenze

• At least 5 years of experience in Regulatory Affairs in pharmaceuticals.
• Experience with medical devices is a plus.
• Fluency in English and Italian required.

Mansioni

• Contribute to EU regulatory strategy for product launch.
• Evaluate complex data to ensure regulatory compliance.
• Manage regulatory activities related to product launch.

Conoscenze

Regulatory knowledge of Italian and EU legislation

Market Access dynamics understanding

Strong communication skills

Ability to analyze complex technical data

Flexibility and willingness to learn

Formazione

Master’s Degree in a Scientific discipline

Postgraduate master’s in Regulatory Affairs

Descrizione del lavoro

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

Application Period: 03.12.2025 – 17.12.2025
Reference Code: 855456

Contact Us:
Viale Certosa 130, 20156 Milano
[e-mail]