Executive Director, CMC Regulatory

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Summary:

This leadership role is responsible for developing and implementing global regulatory strategies in collaboration with Product Development and Material Science and Technology functions to enable and facilitate the development, commercialization, regulatory approval and lifecycle management of novel vaccine products.

Essential Functions:

• Experience developing and implementing regulatory strategies for vaccines and preparing investigational and commercial regulatory applications, i.e., IND/IMPD, BLA/MAA, post-approval changes 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.
• 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.
• Strong technical background in vaccine development and manufacture for commercialization.
• 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.
• Develop and execute globally viable regulatory strategies.
• Develop, author and review regulatory CMC documentation for submission including application documents, correspondence and responses to queries.
• 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.
• Lead interactions and negotiations w/global regulatory authorities for reconciliation of specific technical issues to expedite regulatory application submissions and approvals.
• 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: 

• Education: At a minimum, a BA or BS in a relevant scientific or technical discipline, i.e., chemistry, biochemistry, pharmaceutical sciences, 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
• Regulatory Experience: 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 CMC content.
• Technical Expertise: A thorough understanding of technical, operations, manufacturing and controls of pharmaceutical products and particular experience with vaccine development and commercialization.
• Global Regulatory Expertise: Direct experience engaging multiple health authorities, i.e., FDA, EMA, MHRA, Health Canada, etc., and preparation of regulatory applications for global health authorities. 
• Leadership: Demonstrated ability to lead and manage cross-functional teams, developing and establishing regulatory strategies and preparing regulatory applications including review and submission of CMC documentation to regulatory authorities.
• Lifecycle Management: Direct experience developing regulatory CMC strategies and submissions to effectively deliver post-approval changes and optimizations for commercial vaccines.
• Strategic Regulatory Expertise: Demonstrated record identifying technical and regulatory risks and developing strategies and/or contingencies for mitigation and transparent commitment to quality.
• Business Acumen: 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

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.