Strategic International Regulatory Affairs Lead

vor 21 Stunden


Munich, Bayern, Deutschland Vality One Recruitment GmbH Vollzeit
Job Description

We are seeking a highly skilled Strategic International Regulatory Affairs Lead to join our team at Vality One Recruitment GmbH. As a key member of our organization, you will be responsible for overseeing all approval processes in approximately 35 countries worldwide.

Key Responsibilities
  • Global Approval Process Management: Ensure seamless coordination and compliance with regulatory requirements across the region.
  • Team Leadership: Manage and develop a 12-strong team, fostering a culture of excellence and innovation.
  • Approval Strategy Development: Craft and implement effective approval strategies, meeting deadlines through strategic prioritization.
  • Business Partnership: Collaborate closely with Business Development and Market Access teams to drive overall goals and decision-making.
  • Affiliate Coordination: Establish and maintain strong relationships with authorities, occasionally requiring on-site presence.
Requirements

To succeed in this role, you will need:

  • Educational Background: A degree from a reputable institution.
  • Regulatory Experience: Proven expertise in international marketing authorization of medicinal products.
  • Leadership Skills: Initial management experience is desirable but can be developed on the job.
  • Linguistic Proficiency: Fluency in English and good knowledge of German, with French being an asset.
  • Travel Requirements: Willingness to travel globally, approximately once a month.
What We Offer
  • Development Opportunities: A wide range of career advancement possibilities.
  • Employee Benefits: Comprehensive benefits package, including fitness allowances and more.
  • Team Culture: Regular team events, company celebrations, and a firmly established corporate culture.
  • Work-Life Balance: 40% mobile working and 30 days of vacation per year.
Estimated Salary Range:

The estimated annual salary for this position is €80,000 - €110,000, commensurate with experience and qualifications.



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