You will lead and manage a team of Regional Regulatory Leads (RRL) for EUCAN Region.
Tasks & responsibilities
1. 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.
2. With your expertise, you will ensure the delivery and execution of robust regional regulatory strategies for the EUCAN region, while ensuring our regulatory compliance.
3. You will monitor and enhance the functional and personal development of the team members to drive the team goals.
4. 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.
5. 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
1. 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.
2. Long-term experience in the pharmaceutical industry in Regulatory Affairs, and ideally also in functions outside Regulatory Affairs (e.g. research and development).
3. Several years of practical experience in development projects in Oncology in the EUCAN region, with a special focus on the EU regulatory strategy.
4. 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).
5. Experience with direct Health Authority interactions (e.g. EMA / BfArM) and in handling new developments, registrations and maintenance of products.
6. Proven experience in successful leadership of international and cross-functional project teams.
7. Ability to collaboratively work cross-functionally in- and outside of the regulatory affairs organization with a good understanding of different cultures and their impact.
8. Fluent English skills, both written and spoken.
Ready to contact us?
If you have any questions about the job posting or process, please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330 or via mail: [emailprotected]
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