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Obsidian Therapeutics · 5 hours ago

Director, Clinical Regulatory

United States

Full-time

Remote

Director/Executive

$212K/yr - $258K/yr

12+ years exp

Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. They are looking for a motivated and pragmatic Director, Clinical Regulatory, to lead clinical regulatory strategy and ensure compliance and timely delivery across global regulatory activities.

BiotechnologyHealth CarePharmaceutical

Responsibilities

Plan, prepares, and review clinical submissions to regulatory authorities

Oversee preparation and submission of End-of-Phase (EOP) meeting materials

Own all compliance submissions, including: SUSARs (Suspected Unexpected Serious Adverse Reactions), Investigator updates, Annual reports / DSURs

Manage Draft Label development for OBX-115 and ensure compliance with regulatory standards

Complete and submit Pediatric Study Plan in accordance with regulatory requirements

Lead regulatory activities for Australia and Canada submissions related to pivotal clinical studies

Ensure timely and accurate generic and proprietary name submissions as required

Provide oversight for protocol amendments and ensure regulatory compliance throughout clinical trial lifecycle

Evaluate and recommend improvements to the Regulatory Management System for efficiency and compliance

Lead development and maintenance of the Global Regulatory Plan, ensuring alignment with CMC regulatory strategy and overall forward-looking objectives

Develop comprehensive Pre-BLA and BLA submission plans to support product approval timelines

Collaborate with internal stakeholders (CMC Regulatory, Clinical Development, Clinical Operations, Tech Ops, Regulatory Affairs leadership) to ensure integrated regulatory strategies

Act as a key advisor on regulatory implications for clinical development decisions

Represent clinical-regulatory on cross functional teams

Author regulatory documents in a hands-on manner; manage review, roundtables and incorporation of feedback

Own regulatory project timelines in partnership with project management

Contribute to regulatory agency meeting timing and strategy in conjunction with head of regulatory with CMC regulatory input

Interact with regulatory agencies as needed

Qualification

Clinical Regulatory StrategyRegulatory SubmissionsCellGene TherapyFDA Meetings LeadershipRegulatory ComplianceRegulatory Document AuthoringRegulatory Project ManagementInternational Regulations KnowledgeAnalytical SkillsProblem-Solving AbilitiesAttention to DetailAdaptability

Required

BA/BS in relevant scientific discipline with 12+ years of experience

A minimum of 8+ years directly supporting/overseeing Clinical Regulatory

Experience with Cell or gene therapy in oncology

Experience authoring regulatory documents, managing regulatory timelines and projects

Demonstrated leadership in FDA meetings, ideally EOP/pivotal negotiation

Thorough knowledge of US and international regulations in major regions, including: US, AUS, CAN, EU

Strong familiarity with cell and gene therapy guidance, along with ability to survey new precedent, ICH/FDA guidance documents, and competitor landscape to provide regulatory assessments for questions from cross-functional team

Attention to detail, strong analytical skills, and effective problem-solving abilities, while also demonstrating adaptability to thrive in a fast-paced, high-growth environment