Regulatory Affairs CMC Lead - Gene Therapy (Hybrid)
Jobleads-US
CRISPR Therapeutics, based in Boston, is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative gene therapies. This leadership role requires extensive experience in CMC regulatory requirements for biologics and gene therapies.
The ideal candidate will have over 12 years of regulatory experience and a strong understanding of FDA and EMA guidelines, with a proven record of successful submissions. This position promotes a collaborative work environment with flexible remote options.
#J-18808-Ljbffr Jobleads-US$170k - $220k
...medicine company in Boston is seeking an Associate Director of Regulatory CMC to lead regulatory strategy and bridge development with regulatory roles. This hybrid position requires strong regulatory affairs experience in biotechnology, excellent communication skills,...Suggested- CRISPR Therapeutics, Inc. is seeking an Associate Director, Regulatory Affairs CMC to lead regulatory CMC efforts for a portfolio of gene-based medicines. You will collaborate with cross-functional teams and partners to devise innovative regulatory strategies while coordinating...SuggestedContract workWorldwide
$177k - $278.08k
...delivers transformative therapies to patients. By... ...is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization... ...the GRA CMC Franchise Lead for TAK-079 Independently... ...classified as "hybrid" following Takeda's Hybrid...SuggestedMinimum wageFull timeTemporary workLocal areaRemote workWorldwide- ...is seeking an Associate Director of Quality Systems for Cell & Gene Therapies (VCGT) in Boston. This role partners with cross-functional... ...experience in a matrix environment. Travel up to 15% may be required; hybrid work options are available. #J-18808-Ljbffr Vertex...Suggested
$212k - $333.19k
...organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic... ...to patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human Factors, you...SuggestedMinimum wageFull timeTemporary workLocal areaWorldwideNight shift$211.5k - $258.5k
...delivering category‑leading precision therapies to transform the lives... ...Summary The Director, Regulatory Strategy - Global... ...member of the Regulatory Affairs team, this individual... ...& Location Hybrid - This position follows... ...alignment with clinical, CMC, and non‑clinical development...Local areaFlexible hours2 days per week- ...Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory...
$212k - $333.19k
...and delivers transformative therapies to patients. By focusing R&D... ...as a Senior Director, Global Regulatory Lead - Oncology, where you will... ...concepts within regulatory affairs and implications across the... ...is currently classified as "hybrid" following Takeda's Hybrid and...Minimum wageTemporary workLocal areaRemote workWorldwide- Ellie Mental Health in Newton, MA is seeking licensed mental health counselors (LMHC) for a hybrid role that aims to ignite creativity while reducing traditional therapy barriers and offering strong support. You will supervise other counselors, evaluate diagnoses, craft...Full timeFlexible hours
- Takeda is seeking a senior Regulatory CMC lead in Boston, hybrid: you will own global CMC strategy and drive major submissions across development and lifecycle. You will collaborate with Regulatory, Development, and Commercial teams, negotiate with Health Authorities, and...
$150k - $165k
...organizational and interpersonal skills. Ideal candidates will excel in a dynamic environment, demonstrating an urgency for developing essential gene-based medicines. The position offers a competitive salary between $150,000 to $165,000, plus bonuses and benefits. #J-18808-Ljbffr...$151.2k - $226.8k
...lethality to discover and develop therapies that take aim at critical... ...areas such as tumor suppressor gene loss and their contribution to... ...items, training compliance) Lead QMS simplification/optimization... ...near Fenway Park, on a flexible/hybrid schedule? Will you require...Contract workFor contractorsFor subcontractorWork at officeVisa sponsorshipFlexible hours- A public Biotech company in Boston is seeking a Regulatory Affairs CMC Manager/Senior Manager to support biologic products' global development and registration. The ideal candidate will lead the submission of regulatory documentation, ensuring compliance with FDA and EMA...
$151.2k - $226.8k
...synthetic lethality to discover and develop therapies that take aim at critical targets in... ...into novel areas such as tumor suppressor gene loss and their contribution to the ability... ...time, overdue items, training compliance)Lead QMS simplification/optimization, including...$204k - $281k
About This Role:As the CMC Asset Lead, you will be an integral part of the PO&T Nephrology team, focusing on the development and launch of... ...that are essential for the company's strategic goals.This is a hybrid role that can be based in any of our US offices (RTP, NC or Cambridge...Full timeTemporary workLocal area$206k - $257.5k
...launched our fourth therapy and the first ever gene therapy to treat Duchenne... ..., Global Medical Affairs Strategy and Field, the MSL Team Lead is responsible for the... ...complying with industry and regulatory compliance guidelines... ...position is hybrid, you will be expected...Full time$240k - $360k
...Cystic Fibrosis (CF), Casgevy, a gene therapy for sickle cell disease and... ...of the kidney that can lead to end-stage-renal disease. IgAN... ...Real World Evidence, Government Affairs and Public Policy and to... ...much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible...Summer workRemote workWorldwideFlexible hours2 days per week- ...Therapeutics is seeking a VP, Clinical Development to lead the metabolic franchise and serve as the medical lead for base editing gene therapies. The role reports to the EVP, Head of... ...communicate Beam's vision to stakeholders. Hybrid role with Cambridge onsite presence...
- ...evidence-based ABA practices to improve outcomes for children and families, with a blend of in-person and telehealth services. This hybrid role includes 10-15% in-person supervision per client, up to 30 miles travel for sessions and parent training as needed. #J-18808-...Part time
$100k - $115k
...in Massachusetts is seeking an Information Security Manager to lead cloud security across our Azure environment and align controls with... ...and data operations to advance CHIA’s security program. This hybrid role includes working in our Boston office at 501 Boylston...Work at officeRemote work2 days per week- ...own the end-to-end U.S. payroll function for all employees. The role combines data, compliance, audits, and system optimization in a hybrid environment. You will partner with HR, Finance, IT, and Benefits to ensure accurate payroll processing, handle year-end...
- ...Anagram Therapeutics, Inc. is seeking an Associate Director of Regulatory Affairs CMC to lead regulatory CMC activities across our portfolio through all development stages in a fast-paced biotech environment. You will develop regulatory-CMC strategies, coordinate INDs...
- ...seeking an International Tax Manager based in Boston. This role will lead the end-to-end US international corporate tax and foreign tax... ...strong educational background in commerce or accounting. Working conditions are hybrid with in-office days required. #J-18808-LjbffrWork at office
- ...seeking a Senior Business Development professional to lead end‑to‑end transaction processes across therapy areas. You will assemble senior, cross‑functional... ...cases to senior leadership in a fast‑paced environment. Hybrid work requires in‑office presence about three days...Work at office
- ...partnering with cross-functional teams to harmonize procedures and drive improvements. The role reports to the Director of Quality and leads APQR/QPQA, Data Integrity, and risk management initiatives, with a focus on scalable, compliant processes and a strong quality...
$75k - $110k
A leading online insurance marketplace is hiring a Senior Contracts and Compliance Specialist to support the Legal team in regulatory compliance and commercial contracting. Responsibilities include... ...'s degree. This is a full-time hybrid role with a salary range of $75,...Full timeContract work- ...of Pharmacy Compliance Coordination to lead our controlled substance compliance program... ...with Pharmacy Ops, Legal, and Regulatory Affairs to ensure adherence to state and federal... ...regulations. The position supports flexible/hybrid work with 3 in-person days at core...Remote workFlexible hours
- ...seeks a COB/TPL Recoveries Supervisor to oversee end-to-end COB and third-party liability recovery efforts within a hybrid work environment. You will lead the Recoveries Team, drive process improvements, and ensure compliance with applicable laws and policies....
- Vertex Pharmaceuticals seeks a CMC Quality Compliance Director to lead inspection readiness and compliance for internal and external GMP sites. You will... ..., and collaboration with cross-functional teams. This hybrid/on-site eligible position emphasizes scalable programs...
- American Family Insurance seeks a Regulatory Reporting & Compliance Specialist in a hybrid role, requiring at least 10 days a month in the office. This position entails ensuring compliance with state regulations and submitting essential filings. The ideal candidate will...Work at office
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