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- 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. Candidates at the Director level would be expected to have significant years of additional experience.
- Excellent CMC technical writing and communications skills with a strong background in small molecules, ideally solid-oral dose formulations, manufacturing, and regulatory writing.
- Experience in 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 and understanding of applicable global regulations required - cGMP, global regulatory guidance, compendial requirements, including 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 required.
- 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.
- Flexibility and ability to work in a fast-paced, dynamic environment with limited supervision.
- Proven ability to manage multiple tasks and associated deadlines.
Additional InformationThe anticipated salary range for candidates who will work in our South San Francisco location is between $220,000-$270,000 for the Director level and $250,000-$300,000 for Senior Director, level candidates . 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. This position is not eligible for H-1B visa sponsorship.
