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
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Senior Global Regulatory Affairs: CMC/Devices Lead in Boston, MA vacancy
$137k - $215.27k
Initial Therapeutics, Inc. is looking for a professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory CMC or Device experience and a BS/BA degree in a scientific discipline. Responsibilities include executing regulatory...Senior- Responsibilities Lead development and implementation of regulatory strategies for pure device and drug-device combination products with a... ...management. Maintain and communicate CMC/quality guidance and... ...foundational subject matter expert for global Human Factors regulation for...SeniorNight shift
$212k - $333.19k
...therapies to patients worldwide. About the role As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human Factors, you... ...driving prospective and proactive implementation. Globally influences and serves as a key opinion leader and...SeniorFull timeTemporary workLocal areaWorldwideNight shift$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 of 6 years of experience in regulatory CMC or related fields and a strong foundation in scientific principles...Senior- Alnylam Pharmaceuticals is seeking a Senior Manager, Regulatory Affairs CMC Development in Cambridge, MA. In this hybrid position, you will be responsible for implementing the global regulatory CMC strategy, shaping regulatory strategies for innovative modalities like oligonucleotide...Senior
- ...Therapeutics, Inc. is seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing & Controls. The successful candidate will lead the development of regulatory CMC strategies and manage submissions critical to product lifecycle...Senior
Initial Therapeutics, Inc.
Boston, MA3 days ago $137k - $215.27k
...patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization. It contributes to the team’s... ...critical functions: With some supervision, leads the execution of regulatory CMC investigational...SeniorFull timeTemporary workLocal areaRemote workWorldwide- 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
$208.2k - $327.14k
...lasting impact on patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of the global... ...such as understanding broad concepts within regulatory affairs and implications across the organization and globally;...SeniorMinimum wageFull timeTemporary workLocal areaWorldwide$90 - $130 per hour
...Title Project Manager (Medical Devices III) Position Type Contract... ...manufacturing readiness, and regulatory submission activities. The... ...Device Development, Regulatory Affairs, Quality, Manufacturing, and... ...timelines. Responsibilities Lead integrated project plans focused...SeniorContract 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
$208.2k - $327.14k
A leading global R&D organization is seeking a Senior Director, Global Regulatory Lead - Oncology. This role involves leading global regulatory strategy and engaging with cross-functional teams to ensure the success of innovative oncology therapies. The successful candidate...Senior- Takeda is seeking a Senior Director, Global Regulatory Lead for Oncology in Boston, MA. This role involves leading global regulatory strategy for complex oncology projects, with responsibilities that include overseeing FDA submissions and ensuring compliance with regulatory...Senior
- ...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...
Takeda
Boston, MA1 day ago $238k - $374k
...Initial Therapeutics, Inc. is looking for an Executive Director of Global Regulatory Affairs in Boston, MA. This role entails leading a team to oversee the regulatory strategy for medical devices and drug-device combination products. The successful candidate will have...Initial Therapeutics, Inc.
Boston, MA3 days ago$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- ...thing. Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for... ...compliance with FDA expectations and global standards. Prepare and review... ...of experience in CMC regulatory affairs mainly in the U.S., with a focus...Local area
- Takeda is seeking a Senior Director and Regulatory Platform Lead in Boston, MA to provide strategic leadership in regulatory affairs for combination products and devices. The candidate will develop and implement... ..., and deep knowledge of global regulatory processes. Takeda...
$212k - $333.19k
...empower you to shine? Join us as a Senior Director, Global Program Lead- Neuroscience in our Cambridge, MA office... ...Committed to simultaneously driving regulatory approval as well as launch and... ...Commercial Subteam, Pharmaceutical Sciences (CMC) Subteam, etc. to the GPT through...SeniorMinimum wageFull timeTemporary workWork at officeLocal areaRemote workWorldwide- Sanofi is seeking a Global Atopic Dermatitis Medical Lead based in Cambridge, MA. The role involves steering the medical strategy to establish Dupixent... ...degree in life sciences and over 8 years of medical affairs experience, focusing on dermatology. This position offers...Senior
- QSIC is seeking a Senior Manager to lead Retail Media GTM and global market expansion. In this role, you will create the retailer marketing function from the ground up and develop the go-to-market strategy for QSIC's retailer partners. Your responsibilities include leading...Senior
- RBW Consulting LLP is seeking two experienced Senior Clinical Project Managers to lead global oncology clinical trials. The position involves operational execution of Phase I-III studies and managing CROs in an innovative biotech environment. Successful candidates will...Senior
- Accenture is seeking a Workday Financials Lead in Boston, MA to manage teams and deliver HR and financial management solutions. You'll be part of a global team, ensuring project success through client education and innovation. Candidates should have a Workday Financials...Senior
$137k - $165k
A technology company in Boston is seeking a Senior Manager, Global Trade Compliance to lead the company's export control program. This strategic role includes designing policies for export classification, licensing, and compliance with U.S. and international regulations...Senior- Ernst & Young Oman is seeking a Senior in Global Trade to manage trade automation solutions using Thomson Reuters OSGT. The candidate will work with a team to implement software solutions and deliver high-quality outputs for clients. The role requires a Bachelor's degree...SeniorFlexible hours
$110k - $120k
Allied Global Marketing in Boston, MA is looking for a Senior Billing Manager to lead and optimize the billing function in a fast-paced media agency environment. The ideal candidate will manage a small team, oversee international billing processes, and drive improvements...Senior- A global sportswear company is looking for a GSOC Lead Analyst to manage security operations and oversee incident management. This role requires leadership in crisis situations, collaboration with various teams, and the ability to deliver clear communications during critical...SeniorFlexible hours
- Vertex Pharmaceuticals in Boston, MA is seeking a Senior Director of Global Value & Access Strategy for povetacicept, focusing on IgA nephropathy. This role involves leading the development of global market access strategies and managing cross-functional teams to ensure...Senior
- Nike Inc. is searching for a Senior Marketplace Merchant to spearhead marketplace strategy and seasonal assortment for Converse. The role... ...merchandising background, elevating brand presence across global wholesale markets. This position involves analyzing market trends...SeniorSeasonal work
$85.6k - $128.4k
Wizards of the Coast LLC is seeking a Senior Accountant to join our Controllership team in Boston. This role involves supporting daily operations, preparing reconciliations, and contributing to the global financial close process. The ideal candidate will have a Bachelor...Senior
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Global Regulatory Affairs: CMC/Devices Lead. Be the first to apply!
Related searches
- senior cloud service delivery manager Boston, MA
- senior business analyst contract Boston, MA
- senior product design engineer Boston, MA
- senior game producer Boston, MA
- senior software manager Boston, MA
- senior manager business analytics Boston, MA
- senior marketing account manager Boston, MA
- senior marketing manager Boston, MA
- senior contracts analyst Boston, MA
- sr operations manager Boston, MA