Director, Clinical Regulatory

Job not on LinkedIn

3 days ago

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

💵 $211.5k - $258.5k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

🦅 H1B Visa Sponsor

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Obsidian Therapeutics

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Biotechnology • Pharmaceuticals

Obsidian Therapeutics is a leading biotechnology company pioneering in the field of precision cell and gene therapy. Utilizing its proprietary cytoDRiVE® platform, the company engineers precision medicines by harnessing the power of regulated therapeutic proteins. Obsidian's innovative programs, including the OBX-115, target advanced melanoma and have been recognized by the FDA with both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations. Their pipeline of investigational therapies is designed to offer new hope for patients with unmet medical needs.

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 Series C on 2024-04

📋 Description

• Plan, prepare, 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.

🎯 Requirements

• BA/BS in relevant scientific discipline with 12+ years of experience. (Advanced degree is a plus) • 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

🏖️ Benefits

• comprehensive medical, dental, and vision coverage • company contributions to health savings and retirement accounts • ample paid time off • access to wellness programs • rich career growth opportunities