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Senior Director/ Director, CMC Regulatory Affairs

ORIC Pharmaceuticals Inc.

South San Francisco, CA

ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by overcoming resistance in cancer. Our product candidates include ORIC‑944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and enozertinib (ORIC‑114), a brain‑penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. ORIC has offices in South San Francisco and San Diego, California. Reporting to the Chief Technical Officer, we are hiring a Director, CMC Regulatory Affairs to join our Technical Operations team. This role leads CMC regulatory activities and supports all of ORIC’s clinical development programs for oncology products, collaborating closely with regulatory affairs, regulatory operations, quality, CMC, nonclinical and clinical departments. Responsibilities Oversee and direct all CMC regulatory strategies in compliance with global regulatory requirements for the development of ORIC’s products. Provide CMC regulatory support for new and ongoing clinical trials, including management and preparation of CMC document packages for INDs, CTAs and amendments to global regulatory agencies and health authorities. Collaborate with Pharmaceutical Development, Drug Substance, GMP Quality Assurance, Project Management, Clinical Operations, Clinical Supply and Regulatory Operations. Lead preparation and responses for CMC‑related meetings with global RAs and HAs, balancing regulatory requirements and corporate objectives. Maintain current awareness of relevant global CMC requirements and identify and assess global regulatory risks and mitigation plans. Plan, oversee and manage all CMC aspects of regulatory submissions, including strategy for updating existing dossiers and submission of new INDs, CTAs, NDAs, MAAs, etc. Evaluate proposed manufacturing changes for global impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes. Provide hands‑on support in the generation of CMC documents (e.g., Module 2 and Module 3 of eCTD, IMPD, etc.). Qualifications BA/BS, MS, or Ph.D. in a relevant technical discipline or equivalent qualifications and experience. At least 10 + years of highly relevant pharmaceutical/biotechnology experience with strong CMC background (director level expected to have significant additional experience). Excellent CMC technical writing and communication skills with a strong background in small molecules, ideally solid‑oral dose formulations, manufacturing and regulatory writing. Experience addressing CMC‑related regulatory queries from global health authorities. Experience with all phases of pharmaceutical development and related implementation of phase‑appropriate regulatory CMC requirements and strategies. Demonstrated success driving drug product development and managing all aspects of CMC documentation. Excellent working knowledge of applicable global regulations (cGMP, FDA, EMA, ICH, WHO, USP‑NF). Prior experience as primary author of CMC sections of M2 and M3 of IND, NDA and IMPD. Fluency with eCTD structure, differences in regional dossier requirements and software tools commonly used to author, review, format and approve submission documents. Excellent attention to detail and strong computer and organizational skills. Strong team player, fully engaged, hands‑on professional capable of working collaboratively and independently, with excellent verbal and written communication skills. Must be a strong team player who is fully engaged, hands‑on professional capable of working collaboratively and independently, with excellent verbal and written communication skills. Must have a quality mindset and deliver results in an ethical and positive manner. Must not obligate mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory mandatory 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Vacancy posted 4 days ago
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