Job Title: Director, CMC Regulatory Affairs
Job Number: 21252
Location: Cambridge, MA
Casebia Therapeutics is seeking a Director, CMC Regulatory Affairs with a passion for delivering breakthrough therapeutics for patients. The candidate will play an integral part in the growing Regulatory team and will support the developing life-changing therapies using Casebia’s proprietary gene-editing technology. The ideal candidate will have at least 10 years in CMC Regulatory Affairs within the biotech or pharma industries and will be responsible for leading CMC regulatory strategy and providing support to CMC line function in developing, implementing and advising on global Regulatory CMC strategies for Casebia’s products (in vivo as well as ex vivo cellular therapies). This person will define Regulatory CMC submission strategies and plan, construct, direct and write sections of the CMC portion of INDs, CTAs, IMPDs, BLAs and MAAs to support conduct of clinical trials as well as future marking authorization applications. Additionally, the Director, Reg CMC will support Health Authority meetings and coordinate responses to Health Authority inquiries. Gene therapy and/or cellular therapy regulatory experience preferred. Global experience including US, EU and Japan preferred.
- Provide innovative and proactive strategic CMC regulatory leadership to project teams in early research and all stages of development in alignment with the development plan and corporate goals with strong focus on analytical, manufacturing, and facilities compliance.
- Lead the planning, strategy, content and execution of CMC sections of INDs, CTAs, IMPDs, BLAs, and MAAs including briefing documents, supplements, amendments and variations
- Prepare and review submission-ready CMC documentation in support of INDs, CTAs, IMPDs, BLAs, and MAAs including briefing documents, supplements, amendments and variations
- Ensure that regulatory documents are accurate, complete and in compliance with applicable regulatory requirements.
- Support the implementation of manufacturing processes, testing and process changes
- Assess and communicate CMC regulatory requirements to project teams and management applying interpersonal skills and Reg CMC expertise to ensure all development activities are in compliance with applicable regulations and guidelines
- Primary regulatory representative at internal meetings as well as at meetings with regulatory agencies for all CMC related issues
- Conduct routine regulatory surveillance and coordinate comments on new/changing regulations globally
- Manage and ensure compliance with all reporting requirements, including annual / periodic reports
- May manage contract staff and vendors as needed to support Regulatory activities
- A BA/BS in life science or health related field, advanced degree preferred
- 10+ years of CMC regulatory affairs experience in the biopharmaceutical industry
- Experience in the development of cell or gene therapies strongly preferred with a minimum of 7 years in the biotech industry (gene therapy, vaccines, blood products, and/or cell products, etc.)
- Experience in a small biotech company environment also preferred
- Sound knowledge and experience in CMC Regulatory Affairs and associated requirements, plus biopharmaceutical industry experience in clinical trial and drug development work with a record of successful drug development through product approval in the US, and EU, is strongly preferred
- Thorough knowledge of the drug development process including CMC challenges and strategies supporting expedited drug development pathways for rare diseases
- Previous experience in the preparation and submission of regulatory documents (IND/CTA/NDA/BLA/MAA)
- Experience in interfacing and leading successful negotiation with FDA and other Health authorities.
- Demonstrated strategic thinking and implementation in overall drug development
- Ability to work independently with minimal supervision, and to take ownership and responsibility
- Ability to work cooperatively with teams including alliance partners and influence cross-functionally
- Results focused and able to work under pressure and to set and meet deadlines
- Confident with the professional competence to win respect and gain credibility at all levels within and outside the company; capable of representing the company externally
- Demonstrated ability for innovative and flexible strategies
- Adaptable and self-motivated, able to prioritize effectively with strong problem solving and planning abilities
- Demonstrated ability to communicate clearly, concisely, and effectively