Executive Director, Clinical Regulatory - Vaccines
V
VaxcyteVaccine Development
Remote - USFull-TimeExecutive
Salary299000 - 349000 USD per year
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Job Details
- Experience
- 15+ years industry experience; 10+ years of extensive and relevant regulatory experience
Requirements
- BA or BS in a relevant scientific or technical discipline, i.e., clinical pharmacology, immunology, biology, medicine, bioanalytics or related life sciences.
- 15+ years industry experience that demonstrates technical and regulatory expertise and competence.
- 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.
Responsibilities
- 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.
- 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.
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