Executive Director, Regulatory Affairs – Clinical European/Global Focus

Summary:

This leadership role is responsible for developing and implementing global regulatory strategies for clinical investigational studies and commercialization of vaccines for both adult and pediatric populations.  In collaboration with Clinical Development and Safety this role is responsible for regulatory guidance that enables and facilitates the preparation of clinical development protocols, interpretation and summary of clinical results, initiation, development and preparation of clinical and pre-clinical regulatory documents, correspondence and responses to regulatory authorities toward commercial regulatory approval of novel vaccine products. 

The role requires experience developing and implementing regulatory strategies for vaccines and preparing investigational and commercial regulatory applications, i.e., IND/IMPD, BLA/MAA, post-approval clinical and safety notifications and global regulatory approvals.   Strong communication skills, in particular, the ability to distill complicated issues and regulatory risks and effectively articulate options and opportunities for reconciliation, are essential.  The Executive Director must be comfortable with interfaces at all levels of the organization, including senior leadership, Level 1 – 4 multi-disciplinary teams, and with external partners, CDMOs/CROs and regulatory authorities.  

The ideal candidate possesses a clinical background in vaccine development and relevant experience in development and execution of clinical protocols.  Regulatory experience including a thorough understanding of global regulatory requirements and expectations, and the ability to influence and shape regulatory strategies in a dynamic environment is imperative.  Strategic vision, attention to detail, and a passion for regulatory excellence are key attributes for success in this position.

Essential Functions:

• Develop and execute globally viable clinical regulatory strategies.
• Develop, author and review regulatory CMC documentation for submission including application documents, correspondence and responses to queries. This includes requests for scientific advice in EU, Switzerland, UK and Canada, etc. 
• Provide regulatory guidance for L2, L3 and L4 cross functional development teams.
• Ensure adherence to current regulatory requirements and alignment with appropriate regulatory guidance (including ICH) and industry best practices.
• Serve as a primary point of contact with regulatory authorities, i.e., FDA, EMA, MHRA, PMDA, Health Canada, etc., as appropriate.
• Contribute to the development of product label claims and justifications for clinical outcomes.
• Lead interactions and negotiations w/global regulatory authorities for reconciliation of specific clinical and pre-clinical issues to expedite regulatory application submissions and approvals.
• Support regulatory requirements for safety/pharmacovigilance notifications to regulatory authorities.
• Provide guidance on contemporary regulatory intelligence, statutory legislation and changes in regulatory authority requirements and expectations.
• Manage cross-functional teams to demonstrate and ensure regulatory compliance.
• Optionally, people development and management may be expected.

Requirements: 

• BA or BS in a relevant scientific or technical discipline, i.e., clinical pharmacology, immunology, biology, medicine, bioanalytics or related life sciences, is required with 15+ years industry experience that demonstrates technical and regulatory expertise and competence.  Graduate education and/or professional certifications or training in regulatory and/or quality are a bonus. Other combinations of education and/or experience may be considered
• 10+ years of extensive and relevant regulatory experience with a proven record of achievement in developing and prosecuting regulatory submissions and application approvals within the pharmaceutical or biotechnology industry with a particular emphasis on vaccines and clinical content.
• A thorough understanding of clinical development, statistics with particular experience with vaccine development and commercialization.
• Direct experience engaging multiple health authorities, i.e., FDA, EMA, MHRA, Health Canada, etc., and preparation of regulatory applications for global health authorities. 
• Demonstrated ability to lead and manage cross-functional teams, developing and establishing regulatory strategies and preparing regulatory applications including review and submission of clinical and pre-clinical documentation to regulatory authorities.
• Direct experience developing clinical regulatory strategies and submissions to effectively manage labelling for global markets and post-approval changes and optimizations for commercial vaccines.
• Demonstrated record identifying clinical and regulatory risks and developing strategies and/or contingencies for mitigation.
• Experience translating and integrating contemporary regulatory intelligence into appropriate internal policies and practice.
• Competencies and Skills:
  • Articulate oral and written communication skills
  • Active listening
  • Strategic and tactical critical thinking
  • Constructive operational productivity
  • Adaptability
  • Flexible and optimistic demeanor

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