Job description

Responsible for contributing to the strategy and execution of regulatory CMC plans for emerging gene therapy portfolio. Will require relocation to Southern California with primarily onsite working policy.

Your Role

Responsible for the regulatory CMC strategy and execution for assigned commercial and development projects, including responsibility for significant contributions to IND/CTA preparation, maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies, e.g., FDA and EMA
Leads development of CMC regulatory plans to ensure optimal product development leading to the earliest possible clinical clearances and/or approvals by relevant regulatory authorities
Provides expertise on global regulatory CMC requirements for multiple scientific areas, such as, but not limited to: biologics modalities (peptides, monoclonal antibodies, cell and gene therapy)
Provides expert advice to product development team within CMC areas on all regulatory issues for the development, planning, compilation and submission of IND/CTA/MAA/NDA/BLA
May lead interactions and negotiations with regulatory agencies during all stages of development and registration
Leads preparation of regulatory submissions (IND/CTA/MAA/NDA/BLA)
Actively engages with stakeholder groups to help shape science based regulatory decision making for multiple scientific areas including; gene therapy, biologics and small molecule
May acts as regulatory CMC liaison within the company, with partner companies, and contract manufacturers (CMOs) or research organizations (CROs)

Requirements:

Bachelor’s degree in life science and 10+ years of experience in regulatory affairs in the pharmaceutical/biotech industry. Individual must have prior project regulatory leadership experience with specific focus on the CMC aspects for large molecules and/or cell/gene therapies, including knowledge of FDA and EMA regulations and guidance for drug development, preparation and management of IND/CTA/MAA/NDA/BLA. Prior experience with preparation and preferably, negotiation to marketing approval in major markets is desirable. OR
Master's degree in life science and 8+ years of similar experience as above
Familiarity with regulatory guidelines and regulations governing gene therapy
Ability to effectively interact and communicate with multiple functions across the organization, including executive management
Requires broad understanding of the processes, procedures and systems used to accomplish the team’s work and familiarity with the underlying concepts in other disciplines within the function
Ability to work as part of and lead multiple teams
Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams
Sees broader picture and longer-term impact on division/company
Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
Excellent project management, strong project leadership skills
Excellent verbal and written communication skills