Hiring: Manager, Regulatory Affairs Company: BioSpace Location: Redwood City, CA Job Posted Time: 2026-09-02 18:07:01 Target Skills & Keywords : Compliance, TestNG About the job Required Skills: •Support the regulatory CMC functions in assigned project(s) to drive global regulatory timelines and milestones throughout the lifecycle of product development. •Manage the preparation and filing of regulatory CMC submissions, commitments, and change amendments. Author and review regulatory CMC documents to ensure that all submissions are of high •Assist senior RA staff in the development of Meeting Requests, Briefing Books and meeting materials for FDA and ex-US regulatory agency meetings, including pre-IND meetings, End of Phase meetings, Scientific Advice, etc. •Review CMC, clinical, and nonclinical documentation, including change controls, certificates of analyses, labels, study reports, clinical protocols, DSURs, Investigator Brochures, to ensure GxP and regulatory compliance. •Assist in maintenance and tracking of company databases, including regulatory submissions, agency communications, commitments, agency information requests and responses, etc. •Interface with functional areas, external partners and consultants, as •Maintain knowledge of current global regulations and guidance governing drugs and biologics in all phases of development and communicate changes in regulatory information to cross-functional •Opportunity to develop publishing skills related to submission of electronic CTD compliant documentation. Qualifications: •Experienced in FDA and/or ex-US submissions. •Understand the general requirements of INDs, CTAs, DMFs, ARs/DSURs, FT/RMAT/BTD, and amendments. •Strong scientific background with BA/BS degree in life sciences, pharmacy, or other related fields. Advanced degree is preferred. •At least eight years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industry, with five years of Regulatory CMC experience. •Previous experience in quality assurance, analytical testing, manufacturing, and research is •Key Role-related Competencies •Able to facilitate/impact and influence effective planning interactions and discussions. •Able to effectively interact with external parties to information gather and effectively drive projects through to completion to tight timelines. •A good scientific background and understanding with the ability to acquire this knowledge in a short ti Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!