Director, Regulatory Affairs - Chemistry, Manufacturing and Controls
NGM Biopharmaceuticals, Inc. is a biopharmaceutical 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 build a company where innovation and cutting-edge science has provided the foundation for a robust drug discovery engine that has a track record of generating one new IND candidate per year. NGM’s current pipeline of clinical-stage programs consists of five drug candidates targeting liver and metabolic diseases, retinal diseases and cancer. The most advanced drug candidate, aldafermin (NGM282), is in Phase 2b clinical studies in non-alcoholic steatohepatitis (NASH) and is wholly-owned by NGM. Another drug candidate, NGM621, is in a Phase 2 study in geographic atrophy (GA) secondary to age-related macular degeneration (AMD). NGM’s strategic collaboration with Merck, with a current term running to March 2022, provides us with the resources and flexibility to pursue our ambitious R&D goals and further extend our pipeline of novel drug candidates.
NGMBio is seeking a talented and energetic Director, Regulatory Affairs to support Chemistry, Manufacturing and Controls with extensive biopharma experience to join our innovative team.
The Director, Regulatory Affairs Chemistry, Manufacturing and Controls will have the opportunity to oversee and direct all CMC regulatory strategies. The qualified candidate will provide strategic input, perform risk assessments, oversee and help lead health authority interactions, and oversee preparation of CMC regulatory submissions. The Director will collaborate with functional areas to provide regulatory guidance on quality related issues, accountable for the development, communication and execution of sound regulatory strategies that meet global regulatory requirements and enable business objectives, including identification and communication of regulatory risks and development and execution of risk mitigation strategies. that integrate with plans for other disciplines and company objectives, and to ensure timely and accurate preparation and review of regulatory submissions and related CMC documents. Finally, this person will also be responsible for expanding the team, as well as leading and developing team members as the Regulatory Affairs CMC team grows.
This role will provide the opportunity to:
- Function as Reg CMC lead for assigned products and regions
- Provide strategic Reg CMC interpretation and guidance to project teams from early development through post-approval
- Develop, communicate and execute the regulatory strategy (CMC aspects) to support the lifecycle of assets; determine from a strategic and scientific perspective the content of relevant CMC sections (technical and/or procedural) of project/product specific documents submitted to regulatory agencies (e.g. INDs, BLAs, etc.) and ensure that these documents meet high scientific standards and global regulatory requirements
- Lead project/product-related discussions and provide strategic, scientific and regulatory input, for Reg CMC and/or procedural aspects
- Direct creation of and update to quality sections of regulatory filings; compile/write/review high quality project/product specific CMC documents to be submitted to regulatory agencies and ensure that those documents meet regulatory requirements; review quality submission documents to ensure consistency with related filings, industry standards and regulatory requirements
- Review CMC protocols/test methods; review and approve clinical manufacturing plans and labeling, and authorize drug shipment to clinical sites
- Interact with manufacturing and quality groups, regulatory agencies, contract and partner organizations, regarding Reg CMC issues; assess impact of manufacturing changes pertaining to approved commercial products
- Interface with international affiliates on regional regulatory strategy and implementation plans
- Conduct business development efforts
- Effectively communicate comments/recommendations and proactively engages program teams to establish solution to issues
- Provide coaching, mentoring and knowledge sharing within the Reg CMC skill group
- Review and approve timesheets and expense reports and guiding the performance of assigned staff
Education, Experience, and Skills:
- Bachelor’s degree, or international equivalent, in a science or health related field; PhD preferred, along with 12+ years of relevant Biologics experience in the biopharmaceutical industry (an advanced degree will be considered in lieu of a portion of industry experience); 6-7 years supervisory/management experience
- Advanced knowledge of regulatory requirements, including ICH and FDA strongly preferred
- Diverse experience including biologics, small molecule. Devices/combination products,as well as Marketed Products and international filings preferred
- Experience in Biologics drug development, market applications and commercial lifecycle
- Demonstrated track record of successful submissions to FDA and/or other health authorities, including EMA, PDMA, etc.
- Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously
- Results driven and team oriented, with the ability to influence outcomes as necessary
- Able to develop and implement creative approaches to ensure regulatory success, influence teams and functions in defining global technical regulatory strategies
- Able to innovate, analyze, and solve problems with minimal supervision
- Exceptionally keen attention to detail
- Demonstrated ability to lead employees to achieve company and client goals
- Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.
- Excellent interpersonal, verbal and written communication skills as well as the ability to effectively lead and influence others are essential in this collaborative work environment.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
NGM offers a creative, collaborative, highly challenging scientific environment, along with a strong compensation package that includes salary, stock options, employee stock purchase program participation, 401(k) and a comprehensive, industry-leading, benefits package.
Interested applicants should click "Apply"
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