CMC Regulatory Manager - Cell & Gene Therapy
$70 - $80 per hourVertex Pharmaceuticals
Vertex Pharmaceuticals is seeking a Chemistry Manufacturing Controls Manager to support the execution of cell and gene therapy regulatory CMC strategies. This role involves planning and preparing regulatory CMC documentation while providing guidance to cross-functional teams to ensure compliance with international regulations. The ideal candidate should hold a Bachelor's degree in a related life sciences field and possess at least 5 years of relevant experience, particularly in biologics or cell and gene therapy. This role offers a remote position with a pay range of $70/hr. - $80/hr. #J-18808-Ljbffr Vertex Pharmaceuticals
- ...Regulatory Affairs Manager CMC Patients depend on a continuous, compliant supply of medicines reaching the markets that need them. This role... ...partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in...Suggested
$228k - $233k
...advancing transformative therapies for people with... ...an investigational cell-based therapy in... ...The Director, Global Regulatory Affairs leads... ...oncology, cell and gene therapy, and rare diseases... ...experience and manage study specific regulatory... ...understanding of CMC, nonclinical, and...SuggestedLocal areaRemote workFlexible hours$176.4k - $228.25k
...Neura Market is seeking a Manager/Director of CMC Regulatory Affairs to lead the development and implementation of regulatory strategies for small molecule investigational drugs. This role is critical to facilitating clinical research and ensuring compliance with global...SuggestedRemote work- ...this senior role, you will shape the thought leader engagement strategy and build high-impact relationships across the field of cell therapy. The ideal candidate will have a strong background in oncology, proven ability to influence key stakeholders, and excellent communication...Suggested
- ...specializing in Movement Disorders to lead clinical strategy for gene therapy programs. This role requires expertise in clinical trials and collaboration across teams to ensure patient safety and regulatory compliance. With over 6 years in relevant clinical roles and...Suggested
$200k - $250k
Senior Director, Regulatory Strategy Consulting 4 days ago - Be among... ...Development Provide line management and performance management... ..., and/or regulatory CMC. Experience across multiple... ...mABs, ADCs), small molecules, cell and gene therapy, oligonucleotides, peptides...Full timeRemote work$152.15k - $184.37k
Scorpion Therapeutics is seeking a Senior Manager, Competitive Intelligence to lead a comprehensive CI program supporting their multiple myeloma portfolio. This individual will provide strategic intelligence and manage external vendors, reporting directly to the VP of Competitive...$115k - $145k
About This Role Axsome Therapeutics is seeking a Manager/Senior Manager, Regulatory CMC. This role provides regulatory Chemistry Manufacturing Controls (CMC) support for assigned corporate development and commercial programs and is responsible for the regulatory aspects...Work at officeLocal areaRemote work3 days per week$220k - $250k
Iovance Biotherapeutics, Inc. is seeking a Director, Regulatory CMC to lead drug development programs with a focus on global regulatory strategy... ...development experience is required, as well as the ability to manage multiple projects simultaneously. The position offers a salary...$176.4k - $228.25k
...Impact You’ll Make Lead development and implementation of CMC regulatory strategy for small molecule investigational drugs in global... ...CMC submissions and meetings. Strategize , plan, write, manage internal and external contributors and review region specific...Local areaRemote workWork from homeWorldwide$125k - $145k
...team, then we would like to hear from you. About The Role The Manager, Regulatory Affairs will support the development and execution of... ...regulatory strategies for assigned programs, with a balanced focus on CMC and Clinical Regulatory Affairs. This role will serve as a...Contract workRemote workFlexible hours$120k - $150k
...Supervisor to oversee day-to-day operations of its Stem Cell Lab. The role demands a Bachelor's Degree, NYS DOE... ...years of relevant experience. Responsibilities include managing staff, ensuring compliance with regulatory standards, and maintaining a high-quality work...Monday to Friday- ...transform how Americans eat through nutrition therapy. Berry Street’s platform connects... ...Dietitians and AI-powered tools. From weight management, diabetes, and heart health to kidney... ...workflows, and can translate complex regulatory requirements into clear policies, processes...
$110k - $175k
...industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing... ...opportunities and prove the value of our products. As the Manager of Solution Consulting for our Regulatory team, you will empower a high-performing group of...Work at officeLocal areaWork from homeFlexible hours- A leading biotechnology firm seeks a Manager of Regulatory Affairs to support regulatory strategies and engage with health authorities. This fully... ...and 5+ years in regulatory affairs, ensuring compliance in CMC and clinical environments. Responsibilities include drafting...Remote job
- Providing strategic and operational support, the full-time salaried Regulatory CMC Associate Director will develop and execute multi-product... ...investigational products, lead regulatory submissions, and manage interactions with Health Authorities, all while working remotely...Full timeRemote work
$230k - $270k
...Director, Global Strategy and Program Management , you'll play a key part in this... ..., bringing together development, regulatory, medical, commercial, and market... ...TTFields), a proprietary, groundbreaking therapy designed to disrupt cancer cell division. With us you will find a...Work at officeLocal areaFlexible hours3 days per week$127.31k - $167.1k
...New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms... .... Legend Biotech is seeking a Sr. Manager, Clinical Trial Operations Planning &... ...Clinical Development, IT, ITQA Biostatistics, Regulatory, Project Management, Procurement,...Permanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours$161.6k - $202k
...condition, but most providers don't accept insurance, making therapy too expensive for most people. Headway's mission is to fix this... ...(HITRUST, SOC 2, PCI-DSS, HIPAA), third-party risk management, security awareness training, and technical risk management. You...Work from homeFlexible hours$130k - $200k
...apply for the Associate Director Regulatory Affairs role at Tonix... ...first-in-human clinical trials Manage and prepare complex regulatory... ...Director Regulatory Affairs, Gene Therapy United States $11,000.00-$160... ...Therapy Associate Director, CMC Regulatory Affairs United States...Full timeTemporary workWork at officeLocal areaRemote workFlexible hours$216k - $252k
OpenAI is seeking an experienced Regulatory & Product Assurance IC to scale its Governance, Risk, and Compliance (GRC) function across product launches and regulatory needs. This role involves intensive collaboration with Product, Security, Legal, and GTM teams to maintain...- ...leading healthcare provider in New York is seeking a Laboratory Supervisor to oversee daily laboratory operations. The individual will manage staff, ensure compliance with regulations, and maintain the highest quality of patient care. A Bachelor's Degree and a NYS DOE...Full time
$160k - $210k
...reporting needs. Supports monitoring of key Compliance risk areas. Manages time effectively and regularly meets expected deadlines.... ...000—$210,000 USD. OUR OPPORTUNITY Natera™ is a global leader in cell‑free DNA (cfDNA) testing, dedicated to oncology, women’s health,...Temporary workWork experience placementWork at officeImmediate startRemote workWorldwideHome officeWeekend workAfternoon shift- ...Summary: The Regulatory Affairs Manager ensures regulatory compliance of The Avon/LG H&H US cosmetic, OTC, dietary supplement, and device products from brief through launch in North America. Specifically, the Manager will assemble and review all product-related...Contract workFixed term contractLocal areaFlexible hours
$165k - $220k
...health in the future. The Director, Regulatory Affairs leads global regulatory strategy... ...crossfunctionally with Clinical, Nonclinical, CMC, Quality, Safety, and Regulatory... ...interactions, ensure highquality submissions, and manage regulatory risk across the product...Temporary workWork visa- ...various scientific modalities, including cell and gene therapies, small and large molecules, and... ...lead a high-performing team of project managers and staff; oversee hiring, career development... ...: Conduct market, scientific, regulatory and clinical opportunity assessments...Local area
- ...Regulatory Manager We are seeking an experienced and highly motivated Regulatory Manager to join our Regulatory Affairs team. In this role, you will be responsible for developing and executing regulatory strategies to ensure compliance and successful product approvals...Work at office
- Alcon is looking for a Manager II, Regulatory Affairs Strategy to ensure compliance for our Surgical medical devices. This role is pivotal for timely product access across global markets. You'll support regulatory strategy and partner cross-functionally to meet evolving...
$177k - $229.5k
...revolutionize cancer treatment with therapies designed to activate a... ...Summary As the Area Business Manager (ABM) at Replimune, you’ll take... ...knowledge of healthcare regulatory and enforcement environments.... ...intended to maximize immunogenic cell death and the induction of a...Local areaRemote workFlexible hours$145k - $160k
...aesthetic treatments, weight loss, hormone therapies, or regenerative medicine, our platform... ...and laws change. This role involves managing medical oversight and internal audits, developing... ...to uphold the highest standards of regulatory integrity. Key Responsibilities...Remote workFlexible hours
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