Manager – Regulatory Affairs
NGM Biopharmaceuticals, Inc. is a private 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 six drug candidates in various stages of development, including NGM282 that recently demonstrated proof-of-concept in a Phase 2 study in non-alcoholic steatohepatitis (NASH). In 2015, we entered into a broad, strategic collaboration with Merck that will provide us with the resources and flexibility to pursue our ambitious R&D goals and further extend our pipeline of novel drug candidates.
The Manager of Regulatory Affairs will be responsible for providing regulatory strategy for therapeutic candidates in the metabolic, liver, ophthalmology and oncology therapeutic space, developing regulatory strategies for global development and submissions of therapeutic candidates, planning, coordinating, and authoring of regulatory submissions.
- Responsible for filing INDs, CTAs, briefing documents and maintenance of approved applications including authoring annual reports, amendments as needed.
- Actively contributes in the development of regulatory submission strategies, guide and review submission content, and maintain submission timelines in order to meet business objectives
- Provide regulatory representation to cross-functional product development teams.
- Proactively identify regulatory issues and provide solutions to keep assigned programs on time while maintaining the highest quality.
- Lead efforts for coordinating and driving the content for INDs, IND amendments, CTAs and Agency Requests by working with functional leads.
- Lead, coordinate, write, critically review and provide strategic input on regulatory filing documents (e.g. IMPD, responses to Agency requests, IND module 2 documents).
- Proactively develop regulatory strategies to support CMC, clinical and non-clinical development programs.
- Responsible for project timelines and management of regulatory submissions including authoring and preparing regulatory documentation.
- Establish, track and manage regulatory project timelines, status and documents.
- Provide regulatory assistance and review in clinical operations activities, including review of essential documents and adverse event reporting.
- Perform regulatory research and stay abreast of new/emerging regulations and communicate relevant changes to management and project teams.
- Provide regulatory support for regulatory compliance activities as required.
- Develop and maintain standard operating procedures or local working practices.
- BA/BS, Master’s Degree required, preferably in a health/life sciences or related field
- 3-5 years’ experience in the biotechnology or pharmaceutical industry
- Large molecule experience preferred
- Experience with FDA and EMA regulatory environment
- Experience with early-stage CMC submissions
- Experience in developing and submitting successful regulatory submissions with a thorough understanding of FDA regulations and ICH guidelines.
- Demonstrated ability to work effectively in a team based environment.
- Must be detail-oriented with well-developed organizational and analytical skills.
- Demonstrated excellent written, oral, communication, presentation, planning and interpersonal skills.
- Ability to manage critical projects as part of an interdisciplinary team.
- Must enjoy working in a fast-paced dynamic environment with proven ability to be flexible and adaptable.
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.
Interested applicants should click 'Apply'