Strategic Regulatory Affairs Director for Biotherapies
4 weeks ago
Vitalant is seeking a highly skilled Sr. Director, Biotherapies Regulatory Affairs to lead our regulatory initiatives and ensure compliance with regulatory requirements. As a key member of our team, you will be responsible for developing and executing regional regulatory strategies to support the development, registration, and commercialization of advanced biotherapy products.
Key Responsibilities
- Provide excellent leadership, communication, and interpersonal skills to influence and collaborate effectively with cross-functional teams.
- Develop and execute regional regulatory strategies to support the development, registration, and commercialization of advanced biotherapy products.
- Collaborate with cross-functional teams, including manufacturers, research & development, clinical, collections, and commercial functions, to ensure regulatory compliance and alignment of regulatory activities and development.
- Oversee, prepare, and submit regulatory documents, applications, and licensures to regulatory agencies that govern biotherapies operations and compliance.
- Foster relationships within industry and regional regulatory authorities, including the FDA, to facilitate communication, negotiations, and interactions related to policy, practice standardization, regulatory submission, and approvals.
- Monitor regulatory development, changes, and identify trends while assessing impact on product development and provide strategic guidance to the executive management team.
- Provide regulatory guidance and support for post-marketing activities, including variations, renewals, labeling updates, and compliance initiatives.
- Serve as a subject matter expert on regulatory requirements, guidelines, best practices, and provide training, mentorship, and guidance to regulatory team members and cross-functional stakeholders.
Requirements
- Bachelor's degree in a scientific discipline, such as life sciences, pharmacy, or biosciences.
- Advanced degree preferred.
- RAPS Regulatory Affairs Certification (RAC) Certification preferred.
- Eight years of experience in regulatory affairs within the pharmaceutical or biotech industry.
- Five years of leadership experience.
- Strong knowledge of regulatory requirements and guidelines, including the FDA and ICH guidelines.
About Us
Vitalant is one of the nation's largest nonprofit blood and biotherapies healthcare organizations, providing hospitals and patients across the U.S. a safe blood supply, specialized laboratory services, transfusion medicine expertise, and world-renowned research.
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