Head of Team Regional Regulatory Leads

The Position

Tasks & responsibilities

• In your new role, you will lead and manage a Team of Regional Regulatory Leads responsible for steering and coordination of regional regulatory activities for the EUCAN region required for development, maintenance, and expansion of world-wide marketing authorizations for the assigned BI’s global human pharma portfolio.
• With your expertise, you will ensure the delivery and execution of robust regional regulatory strategies for the EUCAN region, while ensuring our regulatory compliance.
• You will monitor and enhance the functional and personal development of the team members to drive the team goals.
• Furthermore, you will provide support to the Head of RA in establishing objectives, strategies, and priorities for the complete EUCAN team under consideration of the overall objectives.
• You will also lead assigned development projects as well as general projects, while additionally contributing to our common standards and procedures within the group.

Requirements

• Doctoral Degree (e.g. PhD, MD) and/or Master’s Degree in pharmacy or life sciences. Further degrees, e.g., Specialized Pharmacist or Master of Drug Regulatory Affairs are appreciated
• Long-term experience in the pharmaceutical industry in Regulatory Affairs, and ideally also in functions outside Regulatory Affairs (e.g. research and development)
• Several years of practical experience in development projects in Oncology in the EUCAN region, with a special focus on the EU regulatory strategy
• In depth knowledge of international regulatory requirements including the understanding, interpretation, and application of regulatory legislation in the EUCAN region, with focus on EMA (European Medicines Agency)
• Experience with direct Health Authority interactions (e.g. EMA/BfArM) and in handling new developments, registrations and maintenance of products
• Proven experience in successful leadership of international and cross functional project teams
• Ability to collaboratively work cross-functionally in- and outside of the regulatory affairs organization with a good understanding of different cultures and their impact
• Fluent English skills, both written and spoken

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