Remote: Global CMC Regulatory Affairs Lead
NewAmsterdam Pharma Corporation
- Remote job
NewAmsterdam Pharma Corporation is seeking a Senior Manager CMC Regulatory Affairs to oversee global CMC regulatory strategies for clinical development programs and marketing applications. The role is remote and emphasizes collaboration with various departments to ensure compliance with global regulations. The ideal candidate has at least 8 years of industry experience and strong expertise in regulatory submissions. Competitive salary and comprehensive benefits package are offered. #J-18808-Ljbffr NewAmsterdam Pharma Corporation
$177k - $278.08k
...worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...will be the GRA CMC Franchise Lead for TAK-079 Independently... ...following Takeda's Hybrid and Remote Work policy. Takeda Compensation...Remote workMinimum wageFull timeTemporary workLocal areaWorldwide$144.06k - $205.8k
...Astellas Astellas is a global life sciences company... ...leadership role in the Regulatory Affairs department for the... ...Manufacturing and Controls (CMC) aspects of regulatory... ...as a CMC regulatory lead for highly complex... ...based in Westborough, MA. Remote work from anywhere in...Remote workWork at officeLocal areaWork from homeWorldwide- ...SummaryThe Director, Global Regulatory Strategy- Oncology is... ...include Global Regulatory Lead responsibilities for... ...activities and key meetings. Remote-first candidates may... ...in Regulatory Affairs within the pharmaceutical... ...Commercial, Statistics, CMC, and other R&D...Remote workFull timeLocal area
$169.5k - $248.6k
...join us. About the RoleAs the Global Regulatory Lead (GRL), you will be the... ...of regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and... ...of experience in regulatory affairs and/or drug developmentORBachelor... ...and relocation is provided, remote is not available for this role...Remote workLocal areaRelocationFlexible hours$258.68k - $313.46k
...-with-us.Sr Director, Global Regulatory Strategy, NeuroscienceWill... ...as Global Regulatory Lead and US Regional... ...impact BMS, regulatory affairs or projects and provides... ...areas – Drug Development/CMC/Pharmtox/... ...centers. Employees in remote-by-design or lab-based...Remote workHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work- A leading biopharmaceutical company is seeking an Associate Director/Director of Regulatory CMC to manage CMC functions and ensure compliance with global regulations. The ideal candidate has 5-10 years of experience in Regulatory CMC, a strong technical background in relatorette...Remote job
- 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...
- .... is seeking a Senior Manager/Associate Director of Regulatory Affairs CMC to define and execute global CMC regulatory strategies for assigned assets. The role... ...a risk-based approach. Responsibilities include leading global CMC strategies, coordinating timelines, liaising...
- Johnson & Johnson Innovative Medicine seeks a Principal Scientist (Manager) in Global Regulatory Affairs CMC to lead global regulatory strategies for large molecules, including vaccines and cell therapies. You will guide cross-functional teams, develop global dossiers,...
- Johnson & Johnson Innovative Medicine is seeking a Principal Scientist (Manager) in Global Regulatory Affairs, CMC. You will develop global CMC regulatory strategies, lead dossier preparation for large molecules, and guide teams through health authority interactions across...Worldwide
- Johnson & Johnson Innovative Medicine is seeking a Principal Scientist (Manager) in Global Regulatory Affairs, CMC, to lead global regulatory strategies for large molecules and drive regulatory submissions across markets. The role partners with CMC teams to ensure lifecycle...
- ...Innovative Medicine is seeking a Principal Scientist (Manager) for Global Regulatory Affairs, CMC, to drive global regulatory strategies for large molecules, vaccines, and delivery devices. You will lead CMC submissions and align with GRA leadership across markets. The...
- Johnson & Johnson Horsham site seeks a Principal Scientist (Manager) for Global Regulatory Affairs, CMC. You will develop global CMC strategies, lead regulatory dossiers, and provide direction on large molecule programs across markets. Responsibilities include leading...
$177k - $278.08k
...worldwide.Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the... ...understanding broad concepts within regulatory affairs and implications across the... ...hybrid" following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1Takeda Compensation...Remote workMinimum wageTemporary workLocal areaWorldwide- ...Therapeutics, based in Boston, is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative gene... ...submissions. This position promotes a collaborative work environment with flexible remote options. #J-18808-Ljbffr Jobleads-USRemote workFlexible hours
$154.4k - $242.55k
...Takeda is seeking a regulatory affairs specialist to guide global regulatory strategies for digital health and precision medicine initiatives. The ideal... ...engaging with regulatory authorities like the FDA. Remote work is available for this position in the Massachusetts...Remote work- A global pharmaceutical company is seeking an Associate Director for Global Regulatory Affairs. This role involves acting as a Subject Matter Expert and managing all assigned programs... ...skills. This position allows for remote work options. #J-18808-Ljbffr BioSpaceRemote work
- VB Spine, a leading privately held spine company, is seeking a Sr. Staff Regulatory Affairs Specialist to drive global regulatory strategies for complex medical devices. This role partners with cross-functional teams to support development, lifecycle management, and submissions...Remote job
- Solventum, a new healthcare company, seeks a Principal Regulatory Affairs Specialist to lead regulatory submissions for the Dental Solutions portfolio across global markets, including the United States, Canada, and the EU. You will guide regulatory strategy, coordinate...Remote job
- iRhythm Technologies, Inc. is seeking a Senior Regulatory Affairs Specialist to lead global regulatory strategies for wearable medical devices and SaMD. You will drive submissions, interact with authorities, and guide cross-functional teams through lifecycle changes. The...Remote job
- 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...Remote job
$285k - $320k
BridgeBio is hiring for a CMC Regulatory Lead in San Francisco, responsible for leading... ...experience in Regulatory Affairs CMC within the biotech or pharmaceutical... ...be adept at managing complex global submissions. The position is hybrid, with remote work and occasional onsite...Remote job- 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...
$120k - $160k
...- innovating at the speed of life. As a global leader in high-tech filtration, separation... ...everything possible. The US Export Controls Lead will be responsible for managing the Pall... ...Trade Compliance teamand will be fully remote.In this role, you will be required to:...Remote workPermanent employmentFull timeWork at officeWork from homeWork visaFlexible hours- ...biopharmaceutical company in seeking a Senior Director, Regulatory Affairs, CMC. This lead CMC regulatory expert role partners with Regulatory Affairs, Technical Operations, and Development teams to drive global CMC strategy and execution through late-stage development...
- 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,...
$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,...- ...quo for the better. Chiesi Global Rare DiseasesChiesi... ...will doCurrently seeking a Regulatory Affairs (RA) Manager with strong CMC pre and post approval experience... ...Director or Reg CMC Lead, agree on the regulatory... ...flexible working arrangements, remote work options, and tax...Remote workHourly payWork at officeLocal areaRelocation packageFlexible hours
$238k - $374k
...patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination... ..., China).How you will contribute:Leads and develops a team of regulatory leaders... ..." following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1Takeda Compensation...Remote workMinimum wageTemporary workWork at officeLocal areaWorldwide$148.5k - $257.4k
...people around the world. We are a global healthcare leader... ...strategic, tactical and operational regulatory CMC leadership across therapeutic... ...or product lifecycle planning.Leads preparation, critical review,... ...: Indianapolis, IN. A remote option may be considered. Relocation...Remote workRelocation packageFlexible hours
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