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
$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
...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$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- 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
$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$122.25k - $176.58k
Job title: GRA Device Associate - Medical Devices... ...Combination Products (Senior Manager)Location:... ...NJAbout the JobThe Global Regulatory Affairs (GRA) Device team is... ...team is part of the GRA CMC & GRA Device Department... ...with a drug product, leading regulatory efforts in...SeniorFull timeLocal areaWorldwide- 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...
$178.1k - $244.86k
...PURPOSELead development and advancement of Global Patient Access (GPA) strategies across... ...ensuring alignment with enterprise priorities, regulatory requirements, and product lifecycle... ...compliant access globallyACCOUNTABILITIES Lead end-to-end strategy development and execution...SeniorMinimum wageTemporary workLocal areaNight shift$148.5k - $214.5k
...Job title CMC dossier leader Location : Framingham,... ...department within Sanofi R&D Global CMC Development... ...and responsibilities in leading the preparation of CMC dossiers for regulatory submissions to enable advancement... ...and/or regulatory affairs. AI applications and prompt...- ...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
$243.59k - $365.38k
...Summary:Reporting to the Global Medical Head of CardioRenal, the Senior GMAL is a highly experienced Medical Affairs leader with proven vision... ...This individual develops and leads bold medical strategies... ...healthcare system pathways, regulatory landscapes, market access,...SeniorFull timeTemporary workWorldwide$210k - $320k
...committed to establishing the leading, fully integrated platform for... ...motivated Sr. Director / Director of CMC, to lead our advancing... ...suppliers.Work directly with regulatory and key stakeholders on the development... ...review of CMC sections for global regulatory submissions...SeniorFull time$196k - $294k
...that make Klaviyo special.About the RoleKlaviyo is seeking a Senior Lead Product Manager to drive our Enterprise product strategy and lead... ..., retention, and ARR growth.Represent the voice of large, global customers in strategic product discussions.B2C CRM for Enterprise...SeniorWorldwide$237.2k - $372.79k
...shine? Join us as a Global Medical Lead, Dermatology in our Cambridge... ...in global medical affairs, ensuring alignment... ..., market access, and regulatory strategies. This role... ...Project Team (GPT), senior leadership in Global... ...applications, and wearable devices, to enhance patient...Minimum wageTemporary workWork at officeLocal areaRemote workWeekend work$122.25k - $176.58k
Job title: GRA Global AdPromo Excellence LeadLocation... ...global promotional material regulatory review (30%) with... ...diverse portfolio of medical device and diagnostic products... ...SOP revisions under senior guidanceTraining &... ...performing regulatory affairs advertising and promotion...Full timeWork at officeLocal areaWorldwide$204k - $281k
About This Role:As the CMC Asset Lead, you will be an integral part of the PO&T Nephrology team, focusing on the development and launch of... ...commercial launch.Experience in alliance management, preferably global, and understanding of business contracts.Expertise in CMC,...Full timeTemporary workLocal area$170k - $215k
...ProfileFounded in 1977, GMO is a global investment manager committed... ...bubbles and also as a leading climate investor and advocate... ...Overview:GMO seeks to add a senior attorney to its Legal Team. The... ...intermediary relationships, and regulatory requirements, with a particular...SeniorFull timeLocal areaWorldwideFlexible hours$232.5k - $335.83k
Job Title: Global Brand Lead, Transplant (Solid Organ Transplant... ...is a newly created senior role within the... ...collaboration with Medical Affairs, Market Access,... ...Corporate Affairs, Digital, Regulatory, and regional... ...evidence generation, device/presentation, and lifecycle...Full timeLocal area$88.6k - $246.6k
The Solution Implementation Lead is the end‑to‑end execution owner... ...of new connected medical device and digital health solutions.... ...feasibility, operational workflows, regulatory considerations, and validation... ...of FDA guidelines and global regulatory expectations and their...Full timePart timeImmediate startRemote workWorldwide$100k - $145k
...composable, connected apps, leading to higher quality work, improved... ...as a World Economic Forum Global Innovator, a 2024 Deloitte Technology... ...in MedTech. You thrive where regulatory complexity, long deal cycles,... ...that modernizing a medical device manufacturer's operations...SeniorContract workTemporary workWork at officeLocal areaFlexible hours3 days per week$200k - $220k
...Director/ Senior Director, Regulatory CMC Join Us in Tackling Autoimmune Disease at Its... ...work cross‑functionally to lead development and... ...through clinical development and global registration. The candidate... ...biologics and combination biologic/device products is a must. Key...SeniorContract workWorldwideFlexible hours- ...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 &...SeniorFull timeLocal area
$119.7k - $222.3k
...PK Sciences representative to lead the development and use of artificial... ...metabolism, neuroscience, and global health. This position drives... ...and interactions with regulatory agencies, as appropriateProactively... ...to be considered for Senior Principal Scientist.Extensive...SeniorFull time$154.4k - $242.55k
...and Precision MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director),... ...pharmaceutical drug and device.Ensuring that there is strategic... ...without authority at senior level (TET/TET-1, GLOC)Demonstrates... ...strategy, medical affairs, etc.). 5-7 years of...Minimum wageTemporary workLocal area$220k - $290k
...and are exploring regulatory pathways for... ...CRO Regulatory lead supporting OUS development... ...term plans. The Senior Director, Regulatory Affairs has foresight,... ...and implement a global regulatory... ..., biologics and devices) development, registration... ...program. Guide CMC, nonclinical and...SeniorTemporary workFor contractorsWork at officeWeekday work$176k - $346k
...Pioneering is seeking a highly motivated Senior Strategic Transaction Leader to join our... ...offerings, licensing and collaborations, global fundraising as well as and business and corporate... ...transactions. Proven ability to lead negotiations on complex, high-value deals...Senior- ...bring your bold ideas and big dreams and become part of a global team of over 50,000 planners, designers, engineers, scientists... ...a better world. Join us.Job DescriptionAECOM is seeking a Senior Rail Systems Lead to join our World Class Transit/Rail Team in support of our...SeniorWork at officeLocal areaWorldwideRelocationFlexible hours
$110k - $160.91k
...advancing your career with a global leader in environmental consulting... .... This role is focused on leading and overseeing routing and... ...stakeholder engagement, and regulatory documentation and state siting... ...Electric Transmission Line Siting Senior Lead, you will serve as a...SeniorFull timeFixed term contractCasual workWork at officeRemote workFlexible hoursShift work$105.8k - $175k
...good. Your impact We are seeking a Senior Environmental Permitting Lead to drive the successful planning,... ...environmental permitting strategy, regulatory interface, and high-quality technical... ..., and support capabilities of our Global Integrated Delivery (GID) teammates...SeniorFull timeLocal areaRemote workShift work$165k - $190k
Huron is a global consultancy that collaborates with clients to drive strategic growth, ignite innovation and navigate constant change.... ...are seeking an experienced Workday Extend Solution Architect to lead the design, development, and delivery of scalable Workday Extend...SeniorFull timeLocal area
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