Regulatory Operations Senior Associate
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 nonalcoholic 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.
The Regulatory Operations Senior Associate will be responsible for maintaining timelines, formatting & publishing documents, assembling and building Regulatory eCTD submissions such as original INDs, IND amendments and/or CTAs and overseeing & archiving submissions. All will be done in accordance with and requires knowledge in applicable Regulatory Agency regulations, guidelines, and/or specifications (FDA, EMA, ICH, etc).
- Responsible for formatting, editing, proofing, bookmarking and internal document hyperlinks according to guidance and internal processes. Troubleshoot and resolve complex document issues.
- Support US-FDA IND submissions and ex-US submissions activity to global health authorities, including (but not limited to) the preparation, formatting of regulatory documents in the EU regions through CROs and Partners
- Assist in the implementation of systems and procedures used to support regulatory submission including performing QC of content in submission documents and publishing activities
- Responsible for development and implementation of department-wide SOPs, departmental guidelines and/or work processes to streamline all submission activities
- Facilitate interactions with other departments to develop timelines for regulatory submissions
- Provide guidance to multidisciplinary teams on developing submission structure strategies in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (FDA, EMA, ICH, etc.)
- Responsible for maintaining a document management system to align document access and storage with electronic submission and submission archival needs, and maintain paper archives as needed
Minimum: Bachelor’s degree
Experience and Required Skills:
- Minimum 1-2 years’ experience in Pharmaceutical Regulatory Submissions/Operations
- Highly proficient in Microsoft Office suite (especially Word), Adobe Acrobat, electronic document management systems (EDMS, e.g. Veeva Vault, Sharepoint, Documentum) and eCTD viewing tools
- Knowledge/familiarity with eCTD publishing software preferred (e.g. docuBridge, GlobalSubmit PUBLISH, OmniFILE)
- Working knowledge of eCTD authoring templates and Acrobat publishing plug-ins (e.g. ToolBox Pharma, AutoPageX)
- Familiarity with eCTD structure and FDA Comprehensive Table of Headings and Hierarchy, follows and interprets FDA, EMEA and ICH guidelines for electronic submissions
- Strong software troubleshooting skills highly desirable
- Understanding of relevant submission formatting, transmittal and archiving regulations, guidelines and best practices
- Maintains current knowledge of electronic submission requirements and prepares for future initiatives and requirements
- Can work independently, ability to multitask, self-motivated, well organized, detail oriented and proactive in task planning and coordination of activities, works effectively under pressure and has excellent written and verbal communication skills in English
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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