The Associate Director/Director CMC Regulatory Affairs is expected to serve as the global product leader for CMC regulatory strategy of one or more vaccine products. This will include formulating and implementing global CMC regulatory strategies for the development of therapeutic vaccines, lead CMC regulatory activities for assigned projects in line with global requirements, as well as to coordinate all aspects of CMC regulatory submissions relevant to assigned projects or programs.
Develop and implement CMC Regulatory strategies for assigned projects and provide advice and strategic guidance to development teams.
Serves as the CMC regulatory lead on relevant project teams and subteams.
Plans, manages, and executes all CMC regulatory activities for assets in various phases of development.
Establish, in collaboration with the CMC technical team, a harmonized set of CMC templates for global regulatory submissions which satisfy global regulatory requirements.
Serves as the Regulatory lead in Health Authority meetings and leads preparation of CMC activities for meetings with Health Authorities.
Interacts directly and indirectly with FDA and international Health Authorities, as necessary.
Interacts directly and indirectly with internal and external partners on CMC regulatory topics, as necessary.
Ensures line management and key stakeholders are apprised of ongoing developments.
EDUCATION, EXPERIENCE AND COMPETENCIES
BS/MS/Ph.D. or Pharm D in Chemistry, Biochemistry, Molecular Biology, Cellular Biology, Biology or related field.
8-10 years of pharmaceutical product development experience and 5-7 years of vaccine and/or biologic Regulatory CMC experience.
Proven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions and/or product development meetings.
Understanding of scientific principles and regulatory/quality systems and requirements relevant to global vaccine development.
Demonstrates problem-solving ability and generates alternative solutions prior to elevation of issues to Manager.
Genocea is developing therapeutics at the forefront of the T cell revolution. T cells are increasingly recognized as a critical element of the body’s protective immune response to a wide range of pathogens and diseases. While traditional immunotherapy discovery methods have largely used predictive algorithms to find target antigens, we have been able to successfully leverage ATLAS™, our proprietar...y, high-throughput technology platform, to identify target antigens of T cells based on actual human immune responses, enabling the rapid development of therapeutic vaccines that stimulate human protective immunity. We have advanced our lead candidate, GEN-003, a novel T cell-enabled immunotherapy for genital herpes, into Phase 2 clinical development, while also exploring earlier-stage candidates in immuno-oncology.