Senior Global Regulatory Affairs: CMC/Devices Lead
Katalyst CRO
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 affairs, candidates should have 6+ years of relevant experience and a BS/BA in a scientific discipline. Strong analytical and communication skills are essential for this role. #J-18808-Ljbffr
$212k - $333.19k
...life‑changing therapies to patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human Factors, you... ...driving prospective and proactive implementation. Globally influence and serve as a key opinion leader and resource...SeniorMinimum wageFull timeTemporary workLocal areaWorldwideNight shift$137k - $215.27k
...patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team... ...functions as follows: With some supervision, leads the execution of regulatory CMC...SeniorMinimum wageTemporary workLocal areaRemote workWorldwide- 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...Suggested
$212k - $333.19k
...lasting impact on patients worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of the global regulatory... ...such as understanding broad concepts within regulatory affairs and implications across the organization and globally;...SeniorMinimum wageTemporary workLocal areaRemote workWorldwide$193k - $210k
A pharmaceutical firm in Cambridge, MA seeks a Senior Regulatory Affairs Manager to lead the development and execution of regulatory strategies throughout... ...alignment with clinical plans and incorporating global Health Authority feedback. This role offers a competitive...Senior- A leading life sciences company is seeking a Senior Regulatory Affairs Manager to lead their dynamic team through global clinical trials. The role involves driving submission planning, ensuring compliance with regulatory authorities, and managing multiple priorities. Candidates...SeniorRemote job
- Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global Regulatory Leads, Senior Director is responsible for ensuring that... ..., enhancing their skills and knowledge in regulatory affairs Strong strategic planner with a proven ability to...SeniorFull timeLocal area
- ...6 Job Description: This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team... ...& Responsibilities: With some supervision, leads the execution of regulatory CMC investigational...Senior
$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,...- 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...
- ...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...Senior
$212k - $333.19k
...empower you to shine? Join us as a Senior Director, Global Program Lead- Neuroscience in our Cambridge, MA office... ...to simultaneously driving regulatory approval as well as launch and global... ...Commercial Subteam, Pharmaceutical Sciences (CMC) Subteam, etc. to the GPT through...SeniorMinimum wageTemporary workWork at officeLocal areaRemote work- A healthcare technology company is seeking a Sr. Regulatory Affairs Specialist in Somerville, Massachusetts, to support the commercialization of its digital products and AI technologies. The role involves providing regulatory input on product development, maintaining compliance...SeniorRemote job
- Sanofi seeks a Device Quality Engineer to lead risk management and post-market surveillance for medical devices and drug-device combinations. You will oversee global processes, ensure ISO 14971 compliance, and collaborate with cross-functional teams to safeguard patient...
$240k - $360k
...autoimmune disease of the kidney that can lead to end-stage-renal disease. IgAN is... ...gravis (gMG). Vertex is seeking a Senior Director of Global Value & Access Strategy (GVAS) for povetacicept... ...HEOR, Real World Evidence, Government Affairs and Public Policy and to ensure...SeniorSummer workRemote workWorldwideFlexible hours2 days per week- Avalyn Pharmaceuticals seeks a Senior Manager, Regulatory Affairs to drive global regulatory strategy and execution for inhaled drug-device products. You will report to the SVP, Regulatory Affairs and contribute to regulatory submissions, health authority interactions,...
- Takeda is looking for a Senior Director and Regulatory Platform Lead in Boston, MA, to lead the development of innovative regulatory strategies for device and drug-device combinations. This position... ...strategies, interfacing with global health authorities, and ensuring...
$202.5k - $337.5k
Global CMC Automation and Robotics Leader 2 weeks ago Be among the first... ...robots across CMC Build and lead a team of advanced automation... ...transversal collaboration Device driver development and... ...Discover Extraordinary - together. Seniority Level Director Employment...Full timeLocal area- CRISPR Therapeutics, Inc. is seeking an Associate Director, Regulatory Affairs CMC to lead regulatory CMC efforts for a portfolio of gene-based... ...complex CMC topics, prepare high-quality submissions, and guide global teams through INDs, CTAs, #J-18808-Ljbffr Crispr...Contract workWorldwide
- ...Beeline Medicines in the United States is seeking a Senior Director, Regulatory Affairs CMC – Small Molecules to lead regulatory strategy for all CMC activities across... ...and inflammation portfolio. You will shape global regulatory submissions, oversee IND/CTA through NDA...Senior
- Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC - Biologics to lead regulatory science for biologics assets across the development lifecycle. You will drive global CMC strategy, author submissions, and coordinate with Process Development, Analytical...Senior
$183.75k - $336.88k
...Position Summary: As the Senior Director, Early Phase CMC Medicine Research Leader... ...project matrix leaders who lead programs in support of... ...supply chain, quality and CMC regulatory strategy through... ...disease together. GSK is a global biopharma company with a purpose...SeniorFull timeLocal area- Rhythm Pharmaceuticals, Inc. is seeking an experienced Regulatory CMC professional to execute high-quality, compliant CMC deliverables... .... This individual contributor role collaborates with Global Regulatory Affairs, Technical Operations, and Quality to ensure timely,...Senior
- State Street is seeking a Client Pod Senior Lead to own end-to-end AOIA client service across all products and services. You will lead a... ...issues. In collaboration with Relationship Management, Product and Global Delivery, you will ensure service readiness, capacity...Senior
- .... This full-time permanent position requires U.S. citizenship or Green Card status, along with a Bachelor's degree or equivalent experience. Communication skills and the ability to work in a global delivery environment are essential. #J-18808-Ljbffr Career Guidant Inc.SeniorPermanent employmentFull time
$211.5k - $258.5k
...delivering category‑leading precision therapies to... ...Summary The Director, Regulatory Strategy - Global Regulatory Lead is... ...member of the Regulatory Affairs team, this individual... ...with clinical, CMC, and non‑clinical development... ...and involving senior management at key decision...Local areaFlexible hours2 days per week- Novocure Inc in Portsmouth, NH seeks a Senior Manager, Assistant Controller, North America / Global SOX Lead to strengthen financial controls and drive the global SOX program. Hybrid, full-time role with a clear path to a North America Controller. You will partner across...SeniorFull time
- ...Facebook, Instagram, X and YouTube. Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Therapeutic Neurotoxins is responsible for the... ...a Therapeutic Area and supports manager and/or Global Regulatory Lead (GRL) in the development &...SeniorLocal area
- ...A medical device company in Cambridge, MA, is seeking a Regulatory Affairs professional to lead regulatory strategies for Class II medical devices. Responsibilities include managing FDA submissions, ensuring regulatory compliance throughout product development, and collaborating...Senior
- ...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...Remote workFlexible hours
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