Global Regulatory Affairs Manager Biologics Submissions

Bavarian Nordic GmbH; Köniz; Hybrid; CHF 150.000 - 190.000; Vollzeit

Zusammenfassung

Bavarian Nordic is seeking a Regulatory Affairs Manager to lead global regulatory activities for biologic products from multiple hubs, enabling registrations and lifecycle management. Located in Martinsried (Munich), Törishaus (Bern) or Kvistgård, you will coordinate submissions across regions and liaise with health authorities worldwide.

The ideal candidate holds a Master’s in Life Sciences, with at least five years in regulatory affairs within pharma, and fluent English.

Qualifikationen

• Master’s degree in Life Sciences (e.g., Biology, Molecular Biology, Biochemistry, Pharmacy) or a related scientific discipline

Aufgaben

• Lead regulatory activities for lifecycle management projects and global product registrations.
• Develop and execute regulatory strategies for post-approval activities.
• Prepare, coordinate and submit complex regulatory documentation and submissions.
• Act as RA lead within cross-functional teams and provide strategic guidance.
• Coordinate responses to health authority questions and regulatory review procedures.

Jobbeschreibung

Bavarian Nordic is seeking a Regulatory Affairs Manager to lead global regulatory activities for biologic products from multiple hubs, enabling registrations and lifecycle management. Located in Martinsried (Munich), Törishaus (Bern) or Kvistgård, you will coordinate submissions across regions and liaise with health authorities worldwide.

The ideal candidate holds a Master’s in Life Sciences, with at least five years in regulatory affairs within pharma, and fluent English.