Job description

Responsible for contributing to the strategy and execution of regulatory CMC plans for assigned development and commercial projects leading to successful preparation and approval of IND/CTA/MAA/NDA/BLA submissions in a timely and efficient manner focused on development for biologics, small molecules may also be assigned.

This position will require relocation to San Diego for an onsite policy of 4 days/week

Your Contributions (include, but are not limited to):

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, with focus on the CMC aspects for scientific areas such as, biologics and/or small molecule modalities
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) and/or small molecule program management and project teams
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)
Creates, reviews and edits reports and regulatory submissions
Actively engages with stakeholder groups to help shape science based regulatory decision making for multiple scientific areas including; biologics and small molecule
May acts as regulatory CMC liaison within the company, with partner companies, and contract manufacturers (CMOs) or research organizations (CROs)
Other duties as assigned

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 small molecules, large molecules and/or cell/gene therapies, including detailed 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 noted above
Sound knowledge and experienced with gene therapy
Familiarity with regulatory guidelines and regulations governing gene therapy
Able to critically review regulatory scientific documents across all CMC areas for biologics and small molecule modalities, as assigned.
Regulatory expertise in project leadership, preferably negotiation with and conduct of meetings with the FDA and successful preparation and submission of IND/CTA/MAA/NDA/BLA with explicit CMC focus for biologics and/or small molecule modalities.
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
Excellent computer skills
Excellent problem-solving, analytical thinking skills
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
Strong attention to detail
Possess excellent interpersonal skills