Regulatory Affairs Pediatrics - Director Level

Our client is looking for a Regulatory Affairs Director – Pediatrics (50% Contracting Role)

• 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
• 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