Reporting to the Head of Regulatory Affairs, the Manager of Regulatory Affairs will work closely within the regulatory function and with all other company functions in support of product development, with the goal of delivering regulatory milestones for the company’s programs. The RA manager will drive the development and implementation of regulatory strategies and operations ensuring timely delivery of regulatory submissions. The successful candidate will provide regulatory guidance and support to ensure compliance to all regulatory authorities and all aspects of product development, oversee and coordinate submission content finalization and review within cross-functional teams and subject matter experts. The RA Manager is responsible to compile, prepare, and review the various documents for content completeness and compliance with all the regulatory requirements.
· Provides regulatory strategy and operational support to product/portfolio assignments, including but not limited to general regulatory strategies, regulatory requirements in domestic and international markets, and regulatory submission requirements.
· Leads the preparation and submission of documentation to support investigational and marketing registration packages and ensures timelines are met.
· Builds partnerships with other functional areas to ensure strong, clear communication and to identify and address issues in the management of content for regulatory submissions.
· Liaises and negotiates with global regulatory authorities to ensure timely regulatory approvals.
· Develops and implements regulatory submission project and resourcing plans, establishes goals, and measures progress toward critical milestones for major regulatory submissions.
· Actively monitors current and emerging regulatory, and scientific issues and assesses impact on company’s development programs.
· Manages vendors as needed to support regulatory submission goals.
· Facilitates the development of internal and external regulatory policies, guidance, and standards, manages internal regulatory procedures to ensure compliance.
· Bachelor’s degree (advanced degree preferred) in a life science field (Biology, Chemistry, or Pharmaceutical sciences)
· 6+ years’ experience in pharmaceutical or biotech industry in multiple phases of development
· 3+ years Regulatory Affairs experience in drug development and registration activities.
· Demonstrated ability to apply critical thinking, effective problem solving, understanding of regulatory strategies and operations, and the ability to prioritize multiple tasks.
· Proven ability to distill complex plans across multiple programs into an intuitive, clear communication tool to facilitate prioritization and resourcing.
· Proven organizational skills to successfully plan for and manage simultaneous regulatory submissions while managing the routine daily maintenance of existing regulatory applications.
· Strong interpersonal skills and ability to work effectively and build relationships with cross-functional teams, as well as influence many diverse internal and external customer groups.
· Strong knowledge of Microsoft Office suite, Adobe Acrobat, electronic document management systems, and viewing tools.
· Prior biologic experience preferred; cell and gene therapy experience desired.
Passage Bio is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled