Regulatory Affairs CMC Lead - Gene Therapy Programs
Crispr Therapeutics Inc in
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 with contract manufacturers and health authorities worldwide. Reporting to the Head of Regulatory Affairs, you will manage complex CMC topics, prepare high-quality submissions, and guide global teams through INDs, CTAs, #J-18808-Ljbffr
- ...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...SuggestedRemote workFlexible hours
$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$242k - $313.5k
...Senior Director, Regulatory Affairs CMC – Small Molecule Cambridge, Massachusetts, United... ...developing and delivering category-leading precision therapies to transform the lives of people living... ...external CMOs to ensure that CMC programs are designed, documented, and...SuggestedContract workFor contractorsWork at officeLocal area2 days per week- ...Alnylam Pharmaceuticals is seeking an Associate Director of Regulatory Affairs CMC Development to shape global CMC regulatory strategies for development-stage programs, with emphasis on oligonucleotide-based modalities. The role bridges Research, Development, and Regulatory...Suggested
- Arbor Biotechnologies in Cambridge, MA is seeking a Director of Regulatory Affairs to lead regulatory strategy and execution across our preclinical and early clinical programs. Reporting to the Chief Medical Officer, you will serve as the Global Regulatory Lead on program...Suggested
- ...Aldevron, a Danaher operating company, seeks a Senior Program Manager for plasmid DNA programs. This remote role leads complex, multi-program delivery from validation... ...will align scope, schedule, and cost, ensure regulatory readiness and supply continuity, and work across...Remote work
$237.7k - $356.5k
...Senior Director, CMC Product Leader (T1D) will lead the Chemistry,... ...supporting cell therapy products within... ...Sciences - Cell & Gene Therapy. The role... ..., validation, regulatory submission, and... ...representative on the Program Team, a sub-team... ...with Regulatory Affairs and Quality to...Full timeSummer workRemote workFlexible hours2 days per week- ...supporting GMP testing and laboratory operations for gene therapy products. The successful candidate will manage QC lab... ...testing coordination, and sample management. You will lead QC data review, reagent programs, and method performance, working independently and cross...Contract work
$307k - $325.35k
...subsidiary of Bayer AG, is a leading engineered cell therapy company pioneering a new... ...our proprietary CELL+GENE™ platform, we direct cellular... ...Director/Vice President, Program Team Leader is the single... ...beyond. Integrate clinical, regulatory, CMC, nonclinical, safety, commercial...WorldwideShift work- ...Boston seeks a Principal Process Engineer to lead automation and manufacturing solutions for Cell & Genetic Therapies programs. You will guide equipment and system design,... ...regulated biotech environments and deep knowledge of cell & gene therapy processes. #J-18808-Ljbffr...
- ...world. Job Purpose The Director – US RA CMC Team Leader & Innovation, Global CMC Regulatory Affairs is responsible for leading the CMC Regulatory Affairs team with a... ...strategies for FDA, EMA and other agency regulated programs in innovation and registration preparation...
- ...Takeda's Global Regulatory Affairs - CMC team in Cambridge, MA is seeking a Regulatory CMC professional to lead regulatory submissions for investigational, registration and post-approval programs across global markets. With minimal supervision, you will define CMC content...
$177k - $278.08k
...and delivers transformative therapies to patients. By focusing R&D... ...Takeda as a Director, Global Regulatory Lead Oncology where you will be... ...submissions for high-impact oncology programs.How you will contribute:... ...concepts within regulatory affairs and implications across the...Minimum wageLocal areaRemote workWorldwide$212k - $333.19k
...as a Senior Director, Global Program Lead- Neuroscience in our... ...leadersCommitted to simultaneously driving regulatory approval as well as launch... ...modalities such as Cell Therapy or Gene Therapy, large scale... ...Subteam, Pharmaceutical Sciences (CMC) Subteam, etc. to the GPT through...Minimum wageWork at officeLocal areaRemote work- ...is seeking an Associate Director of Chemistry, Manufacturing and Controls to execute global regulatory CMC strategies for investigational and marketed products. You will lead preparation and filing of CMC submissions and manage interactions with Health Authorities for...
- ...Moderna seeks an Associate Director of Global Regulatory Affairs, CMC, to lead LATAM regulatory activities and ensure high-quality CMC submissions... ...strong LATAM knowledge, and the ability to manage multiple programs across vaccines, oncology, or rare diseases. #J-18808-...
$85k - $90k
...clinician to join our Massachusetts team as CBHI Program Director. The role oversees in-home behavioral therapy and mentoring programs and guides staff in treatment... ...of all in-home treatment and programming, lead operations, and support client care. Salary is $85...$129k - $153k
...committed to developing therapies that make a... ...Position Overview Regulatory leaders who leverage... ...Global Regulatory Affairs Strategy Team (... ...regional, labeling and CMC GRAST members to... ...(including leading assigned tasks) while... ...technology, and cell and gene therapy to support...WorldwideRelocation package- Hongene Biotech is seeking an Associate Director / Senior Manager in CMC Project Management in the Boston area. The role reports to the VP, Global Head of CMC & Regulatory and strengthens project management for oligonucleotide contract manufacturing services. Senior/AD...Contract work
- ...Director, Global Regulatory Lead OncologyAt Takeda, we are a forward-looking... ...and delivers transformative therapies to patients. By focusing R&D... ...for high-impact oncology programs.Oversee as well as execute... ...concepts within regulatory affairs and implications across the...Worldwide
$230k - $250k
...Director, Global Regulatory Affairs - Strategy Lead Olema Oncology is a clinical-stage biopharmaceutical... ...Phase 1 monotherapy data from this program across multiple solid tumor types, are... ...approach to developing better therapies and passionate colleagues dedicated...Work at officeFlexible hours2 days per week$237k
...seeks a Senior Director to lead Chemistry, Manufacturing... ...Type 1 Diabetes cell therapy products. The role involves... ...developing integrated CMC plans across development, scale-up, regulatory submission, and... ...functional teams or major programs ~ Deep knowledge of GMP...- ...Apploi seeks a Certified or Registered Respiratory Therapist for a Massachusetts facility launching a pulmonary program focused on preventing rehospitalizations and improving ADLs. The RT will deliver treatments and collaborate with nursing, infection prevention, and physicians...
$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... ...management.Proven track record in matrix leadership across program teams and the full product life cycle, including experience in...Full timeTemporary workLocal area$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...- ...Vertex Pharmaceuticals is seeking an Associate Director, CMC Quality Compliance and Inspection Readiness to drive inspection readiness... ...through audits and CAPA closures. The position demands deep regulatory knowledge, experience with multiple modalities, and proven...
$145 - $170 per hour
...find your next opportunity. Senior Regulatory CMC Lead Compensation: $145.00 - $170.00 Loading... ...support our client’s global Regulatory Affairs team. Created/Revised Date : September... ...CMC leadership for a global biologics program. This role will lead CMC activities...Hourly payFull timeTemporary workLocal areaRemote workMonday to FridayShift work- ...Vertex Pharmaceuticals is seeking a Quality Shop Floor Specialist to oversee floor quality for autologous cell and gene therapy production in a cGMP cleanroom. You will support batch records review, disposition, and ensure compliance with policy, procedures, and regulations...
- ...Royalston Regional School District in Athol, Massachusetts seeks a Secondary Special Education Coordinator to oversee district-wide programs at the secondary level and ensure quality, compliance, and coordination with state and federal guidelines. The role is a full-time...Full time
- ...Tufts Medicine seeks a Pharmacy Manager to lead the 340B program across acute and ambulatory settings. This role reports to Pharmacy leadership and focuses on policy, compliance, reporting, and cross-functional coordination with procurement and HRSA. The successful candidate...
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