Senior Manager / Associate Director – Regulatory Liaison
NGM Biopharmaceuticals, Inc. is a clinical stage biotech company dedicated to discovering and developing the next generation of medicines for the treatment of serious diseases. Our experienced scientific team has joined forces with an impressive group of industry professionals, Nobel Laureates and other distinguished researchers to form a company where innovation and cutting-edge science has provided the foundation for a robust drug discovery engine. To date, NGM Bio has generated a pipeline of seven drug candidates in various stages of development targeting liver, metabolic and ophthalmic diseases and cancer. The most advanced drug candidate, NGM282, is entering Phase 2b clinical studies in non-alcoholic steatohepatitis (NASH). NGM’s strategic collaboration with Merck, which was extended to March 2022, will continue to provide us with the resources and flexibility to pursue our ambitious R&D goals and further extend our pipeline of novel drug candidates.
NGM is an exciting fast paced company with opportunities for career growth. Hands on experience with regulatory strategy both early and late stage biologics. Direct point of contact with FDA on projects. Ability to participate in strategy of nonclinical and clinical development of therapeutic candidates in diabetes, liver diseases, ophthalmic and oncology.
The Senior Manager/Associate Director will develop and implement global regulatory strategies encompassing clinical, non-clinical and CMC disciplines to support the development of multiple early development and late development drug candidates.
This role requires leadership in the development and execution of regulatory strategy with the help of cross-functional project teams and supports interactions with global health authorities and corporate partners with regulatory deliverables and management of regulatory team.
- Lead the preparation, review, assembly and submission of regulatory documentation such as INDs, other regulatory equivalents, IMPDs, expedited program designations, orphan drug applications, annual reporting and pediatric plans.
- Represent Regulatory Affairs in multi-disciplinary teams and senior management for regulatory strategies and development of early and late stage development programs.
- Coordinate and consult with subject matter experts on the content, review and publication and assembly of regulatory documentation
- Lead the strategy and prepare for Health Authority meetings
- Serve as primary liaison with Health Authority for assigned projects
- Provide advice and guidance to project teams on the interpretation and application of relevant regulatory requirements and applicable guidances.
- Manage and build the regulatory group and manage the work of others by providing guidance to his/her team. Manage budgets and project timelines, identify and address gaps in planning and resourcing.
Position will be filled at a level commensurate with experience. Bachelor degree in a life sciences, chemistry, or related discipline with minimum 8 years of experience in Regulatory Affairs. Advanced degree preferred.
Experience working with US and/or ex-US health authorities. Execute work in a detail-oriented manner and guide the successful completion of all submissions. Have strong written and verbal presentation skills. Strong analytical thinking and organization skills. Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to departmental and team colleagues. Has good general knowledge of other related disciplines. Able to work and communicate well within a multidisciplinary project team and to manage multiple projects simultaneously.
NGM offers a creative, collaborative, highly challenging scientific environment, along with a strong compensation package that includes salary, stock options, 401(k) and a comprehensive benefits package.
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