Head of Team Regional Regulatory Leads - Duesseldorf, Deutschland - BI International GmbH

BI International GmbH
BI International GmbH
Geprüftes Unternehmen
Duesseldorf, Deutschland

vor 2 Wochen

Lena Wagner

Geschrieben von:

Lena Wagner

beBee Recruiter
Beschreibung

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 crossfunctionally 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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