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ORIC Pharmaceuticals Inc. · 2 days ago

Senior Director/ Director, CMC Regulatory Affairs

South San Francisco, CA

Full-time

Onsite

Director/Executive

$220K/yr - $300K/yr

10+ years exp

ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. The Director of CMC Regulatory Affairs will lead regulatory activities and support clinical development programs, ensuring compliance with global regulatory requirements and collaborating with various cross-functional teams.

BiopharmaBiotechnologyHealth CarePharmaceuticalTherapeutics

Growth Opportunities

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, 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.)

Qualification

CMC regulatory strategiesCMC technical writingPharmaceutical developmentGlobal regulations knowledgeECTD structureRegulatory CMC requirementsTeam playerAttention to detailCommunication skillsFlexibility

Required

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