Regulatory Affairs Pediatrics Director

vor 1 Woche

Zug, Zug, Schweiz Actalent Vollzeit CHF 120'000 - CHF 180'000 pro Jahr

On behalf of our client, we are currently seeking a Regulatory Affairs Director – Pediatrics for a 50% contract position, fully remote, with the requirement to be based in Switzerland.

*Please note that we can only consider EU/Schengen applications, or valid Swiss permit

Responsibilities:

  • Develops and implements the EU/US and relevant international regulatory strategy for pediatric development of assigned projects aligned with the global regulatory strategy and respective regulatory guidelines
  • Leads cross functional teams for the preparation of the EU/US and relevant international pediatric investigation plan (PIP) / FDA pediatric written request applications
  • Leads the preparation of pediatric related regulatory submissions in accordance with local guidelines, manages the timely finalization of high quality submissions
  • Contributes to response preparation, ensures complete and consistent response packages in line with the global development strategy to secure approvals of pediatric development plans
  • Assures pediatric development is pursued in line with Health Authority requirements and prepares compliance check submissions to secure subsequent timely regulatory applications
  • Responsible to complete commitments and derive and secure regional label updates to expand into pediatric population if data is positive
  • Leads cross functional team to update (PIP / pediatric WR) as needed via modifications / amendments
  • Ensures effective teamwork across Regulatory Affairs and functional areas, enabling rapid and effective submissions, approvals, and maintenance activities
  • Serves as regulatory representative and provides regulatory support for clinical trial applications and for the overall pediatric development program

Requirements
:

  • MSc- degree in Pharmacy, Chemistry, Biochemistry, Biology, Biotechnology or comparable
  • 10+ years' experience in drug development, 8+ years in regulatory
  • Extensive experience in pediatric drug development specifically in the preparation of the EU Pediatric Investigation Plans (PIP) / US Pediatric written request
  • Ability to think strategically and critically evaluate risks to regulatory activities in a business-critical and high-profile development program
  • Proven track record in leading pediatric submissions, interactions with regulatory authorities, approvals across various jurisdictions
  • Previous experience in therapies for rare diseases and small molecules
  • Critical thinking on current regulatory science questions and a good understanding of the corresponding scientific and clinical components
  • Excellent verbal and written communication and presentation skills (English). Fluency in writing regulatory documents such as
    IMPDs, INDs, NDAs, MAAs.
  • Strong team player and ability to work across functions (matrix regulatory team)
  • Comfortable in a small company environment that is fast paced, challenging and where all staff must take a hands-on approach to get results
  • Ability to multi-task and manage workload independently
  • Excited and driven by science and the vision to improve disease management and patient care

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