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 Katalyst CRO
$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$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 influences and serves as a key opinion leader and...SeniorMinimum wageTemporary workLocal areaRemote workWorldwideNight 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 areaImmediate startRemote workWorldwide- Scorpion Therapeutics in Cambridge, Massachusetts is seeking a leader in Global Regulatory Affairs CMC to oversee regulatory strategy and submissions for small molecules and biologics. The ideal candidate should have over 20 years of experience in the industry and a strong...Suggested
- ...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
- 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
$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... ...such as understanding broad concepts within regulatory affairs and implications across the organization and globally;...SeniorMinimum wageTemporary workLocal areaImmediate startRemote workWorldwide$238k - $374k
JobRx, Inc. is seeking an Executive Director for Global Regulatory Affairs CMC Early Development based in Boston. The ideal candidate will provide strategic leadership, overseeing global CMC regulatory strategies for small molecules and biologics through Phase 2, and working...$120k - $180k
Medtronic is seeking a Principal Regulatory Affairs Specialist based in Boston, Massachusetts. In this role, you will be integral to launching new products in the Wound Management portfolio, collaborating with the new product development team to ensure compliance with...Senior- 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...
$92k - $138k
Medtronic is seeking a Senior Regulatory Affairs Specialist in Boston, Massachusetts. This role is primarily responsible for managing regulatory activities for the Basic Energy and Access and Instrument product portfolio. Duties include preparing submissions, interacting...Senior- 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- Job Description This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's... ...& Responsibilities With some supervision, leads the execution of regulatory CMC investigational...Senior
$240k - $360k
Senior Director, Global Value & Access Strategy - povetacicept Vertex Pharmaceuticals is seeking a Senior... ..., reporting to the ED Kidney Lead, to join our dynamic team in Boston, MA... ...HEOR, Real World Evidence, Government Affairs and Public Policy to ensure alignment...SeniorRemote workFlexible hours2 days per week$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- ...and YouTube. Job Description The Senior Director Regulatory Affairs Therapeutic Area Head, GRS, is responsible for the management of global regulatory leads with product and disease state... ...multiple functions (Ad/Promo, Labeling, CMC, devices, Clinical development, etc.) and...SeniorImmediate start
$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...- A health technology company is looking for a Senior Global Product Manager for its Ambulatory & Monitoring Diagnostics Service Solutions team... ...of experience in product management, preferably in medical devices or related fields, along with a Bachelor’s degree. The position...SeniorWork at office
$139k - $223k
Mass Digital Health is seeking a Senior Global Product Manager for Hardware in Cambridge, MA. This role involves defining and managing product... ...of experience in product management, preferably in medical devices or a regulated environment, and a bachelor's degree in a...SeniorWork at office3 days per week- Takeda in Boston is looking for a GRA CMC Product Lead to oversee regulatory CMC strategies and lead submissions for investigational, registration, and post-approval processes. This role requires a strong background in biopharmaceuticals with 10+ years in the industry...
- A leading technology firm is seeking a Senior Compensation Analyst to join their Total Rewards team in Boston. This role involves leading the development and administration of global compensation programs and ensuring compliance. Candidates should have over 5 years of...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
- 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- Cengage Group is seeking a Senior Manager of Financial Reporting in Boston to oversee complex financial reporting processes and SEC compliance... ...experience. The role involves managing financial reporting globally and liaising with various teams, with a competitive salary...Senior
$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 leading health technology firm is seeking a Senior Hardware Engineering Project Manager in Boston, MA, to lead the development of innovative devices. This role involves managing multi-disciplinary engineering teams, coordinating critical milestones, and ensuring project...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
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