Regulatory Affairs CMC Lead - Gene Therapy (Hybrid)
CRISPR Therapeutics
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 CRISPR Therapeutics
$165k - $180k
...Therapeutics in Boston is seeking an Associate Director of Regulatory Affairs CMC to lead the development of novel therapies. In this role, you'll guide cross-functional... ...Affairs CMC related to biologics or cell and gene therapies, exceptional communication abilities,...Suggested- Alnylam Pharmaceuticals is seeking a Senior Manager, Regulatory Affairs CMC Development in Cambridge, MA. In this hybrid position, you will be responsible for... ...strategies. Join Alnylam to help bring groundbreaking therapies to patients. #J-18808-Ljbffr Alnylam PharmaceuticalsSuggested
$212k - $333.19k
...innovation and delivers transformative therapies to patients. By focusing R&D efforts... ...the Role As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations... ...position is currently classified as "hybrid" following Takeda's Hybrid and Remote...SuggestedMinimum wageFull timeTemporary workLocal areaRemote workWorldwideNight shift- GlaxoSmithKline in Cambridge, Massachusetts is seeking a Regulatory Affairs Manager to lead the Chemistry, Manufacturing, and Controls (CMC) regulatory strategy for vaccines. This role... ...relevant experience. This position offers a hybrid work model, requiring regular onsite presence...Suggested
- ...thing. Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for... ...of experience in CMC regulatory affairs mainly in the U.S., with a focus... ...skills. Working Model This role is hybrid. Employees are expected to be on...SuggestedLocal area
$137k - $215.27k
...looking for a professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory CMC or Device... ...strategies and managing submissions. The position offers a hybrid work model, with a salary range of $137,000 to $215,270, encompassing...$137k - $215.27k
Takeda is seeking a Regulatory Affairs professional in Boston, MA to lead regulatory CMC initiatives for various pharmaceutical products. The role requires a minimum... ...relationships with health authorities. This position is hybrid and offers a competitive salary range of $137,00...- A leading biopharmaceutical company is seeking a Director of Regulatory CMC in Boston, MA. This key role involves managing post-approval change activities, ensuring compliance with global regulations, and leading efforts to standardize processes. Candidates should possess...
- 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...
$150k - $165k
...alliance management or business development. The position emphasizes building relationships and negotiating partnerships to develop transformative gene-based medicines, with a base pay range of $150,000 to $165,000 plus bonuses and equity. #J-18808-Ljbffr CRISPR Therapeutics$71.25k - $161.7k
...pharmaceutical industry. Responsibilities include reviewing analytical data, managing laboratory projects, and ensuring adherence to regulatory requirements. The expected compensation ranges from $71,250 to $161,700, and the role requires on-site presence in our Boston lab...$208.2k - $327.14k
...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... ...people around the world. #LI-Hybrid #LI-AA1 Takeda Compensation...Minimum wageFull timeTemporary workLocal areaWorldwide$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$60k - $70k
...with HR policies. Candidates should have a Bachelor's degree and 3-5 years of experience in workforce management. The position is hybrid, requiring onsite presence 3 days a week in Cambridge, MA, with a salary range of $60-70k. Exceptional communication and organization...3 days per week- AECOM is seeking a Senior Rail Systems Lead in Boston, MA to join their World Class Transit/Rail Team. You will lead systems design and... ...expertise in transit/rail systems. The position offers a hybrid work model and is crucial for steering projects contributing to...
- ...Cambridge, seeks a Senior Offset/Industrial Cooperation Manager to lead compliance and policy development in Offset regulations. The... ...specialist advice across departments to enhance compliance and operational efficiency. A hybrid work model is offered. #J-18808-Ljbffr Marshall
- Join Axon as a Direct Tax Manager and help support the company's growth through effective global tax compliance. This hybrid role requires expertise in federal, state, and international tax matters with key responsibilities in managing tax operations and collaborating...
- ...seeking an experienced professional to lead CMC analytical development as Aerska advances... ...submissions in line with ICH guidelines and regulatory expectations from MHRA and FDA.... ...therapeutics to the CNS. By silencing the genes that cause harm, Aerska aims to preserve...
- A leading pharmaceutical firm is seeking a Senior IT Systems Analyst to oversee technology... ...settings, a strong understanding of regulatory compliance, and the ability to enforce SOPs... ...systems. This position offers a hybrid work schedule and competitive benefits package...
- ...background in animal welfare, at least three years of related experience, and holds an Associate or Bachelor’s degree in a relevant field. The position follows a hybrid work model, promoting a balance between on-site and remote work. #J-18808-Ljbffr Charles River LaboratoriesRemote work
- ...proactive and detail-oriented individual who can lead, educate, and inspire our team to achieve... ...strategies to mitigate them. · Ensure Regulatory Compliance: Stay current with EHS... ...available with this position. · This is a hybrid position with 3 days in the office. #J-1...Work at officeLocal areaRelocation
- ...strong leadership and project management skills, along with a Bachelor's degree and relevant healthcare experience. The role offers a hybrid work schedule, requiring at least two days onsite weekly, and includes competitive pay and benefits. Join our team to support...Weekly pay
- 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
- ...agile team committed to developing therapies that make a meaningful... ...External Innovation and Due Diligence Lead? The job is in our Waltham MA Office. This is a hybrid position and is onsite three days... ...protein technology, and cell and gene therapy to support continued...Work at officeLocal areaWorldwide3 days per week
$212k - $333.19k
...Senior Director, Global Regulatory Lead – Oncology At Takeda, we are a forward-looking, world... ...innovation and delivers transformative therapies to patients. By focusing R&D efforts on... ...position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide$110k - $125k
...Supervisor) – Cell and Gene – Cell Based Assay Position... ...of life-changing therapies. With clinical trials... ...research business is a leading global contract research... ...program timelines and CMC milestones. Data Quality... ...standards and or regulatory expectations. Review...Remote jobFull timeContract workTemporary workWork at officeRelocationRelocation packageMonday to FridayShift workNight shiftWeekend workDay shiftAfternoon shift$71.25k - $187k
Eli Lilly and Company is hiring a Scientist in Boston to lead analytical assay development and optimization for AAV viral vectors. This role requires extensive experience in analytical methods, documentation, and collaboration within a regulated environment. The ideal...$88k - $145k
Overview As a Lead Vendor Management Advisor (Strategic/Critical Vendors) with American... ...Identify and mitigate supplier risk by ensuring regulatory, security, and policy compliance and... ...unless specified in the posting In this hybrid role, you will be expected to work a...Full timeContract workLocal areaRelocation package$65k - $70k
Eliot Community Human Services is looking for an AIT Clinician to join its Adult Intensive Team in Boston, MA. This role offers a salary range of $65,000 to $70,000 and requires a Master’s degree in a relevant field. The ideal candidate will provide therapeutic services...Monday to Friday$170.4k - $255.6k
...Salesforce Technical Architecture & Strategy Lead in Boston, MA. This pivotal role... ...operational efficiency in the Cell and Gene Therapy areas. The ideal candidate has a Bachelor... ...GxP compliance. The position allows for hybrid work flexibility and offers a competitive...
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