Director, CMC Regulatory Affairs

Job Description

Job Description

Company Description

ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) 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. For more information, please go to  www.oricpharma.com, and follow us on X or LinkedIn.

Reporting to the Chief Technical Officer, we are currently hiring a Director, CMC Regulatory Affairs, to join our Technical Operations team. This position is responsible for leading CMC regulatory activities and supporting all of ORIC’s clinical development programs for oncology products. The role involves close collaboration with cross-functional teams including regulatory affairs, regulatory operations, quality, CMC, nonclinical, and clinical departments.

Job Description

• 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, e.g., manage / prepare CMC document packages in support of INDs, CTAs and amendments to global regulatory agencies (RAs) and health authorities (HAs)
• Work collaboratively with Pharmaceutical Development, Drug Substance, and GMP Quality Assurance, in addition to 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.
• Planning, oversight, and management of all CMC aspects of regulatory submissions, including strategy for updating existing dossiers, 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

Additional Information

The anticipated salary range for candidates who will work in our South San Francisco location is between  $220,000-$270,000 . The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc.

ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.