Head of Team Regional Regulatory Leads

vor 2 Monaten

Duesseldorf, Deutschland BI International GmbH Vollzeit

**The Position**:
You will lead and manage a team of Regional Regulatory Leads (RRL) for EUCAN Region.

***Tasks & responsibilities**:
In your 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 authorisations for the assigned BI’s global human pharma portfolio.
- delivering and execution of robust regional regulatory strategies for the EUCAN region
- ensuring 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, and general projects.
- You will contribute to 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 pharmaceutical industry in Regulatory Affairs, and ideally also in functions outside Regulatory Affairs (e.g., research and development).
- Several years of practical experiences in development projects in Inflammation in the EUCAN region, with a special focus on the EU regulatory strategy.
- Understanding of different cultures and their impact
- 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 organisation
- Fluent English skills, both written and spoken

***Ready to contact us?**:
Recruitment process:

Step 2: Virtual meeting in the period from mid of April
Step 3: On-site interviews beginning of May

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