Remote Director, Regulatory CMC Global Submissions Leader
TG Therapeutics Inc
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 methodologies, and the ability to manage multiple projects effectively. This role offers a hybrid work environment and opportunities for professional growth. #J-18808-Ljbffr
- ...A leading biopharmaceutical company in Carmel, Indiana, is seeking a Regulatory Affairs professional to support global regulatory CMC activities. This role involves collaborating on submissions for clinical programs and managing CMC regulatory strategies. The ideal candidate...Suggested
$285k - $320k
BridgeBio is hiring for a CMC Regulatory Lead in San Francisco, responsible for... ...for drug approvals and submissions. Candidates should have extensive... ...and be adept at managing complex global submissions. The position is hybrid, with remote work and occasional onsite requirements...Remote job$221k - $286k
...Kite Pharma is seeking a Senior Director of Regulatory CMC in Oceanside, CA, to provide global leadership for the regulatory... ...overseeing global CMC strategies, submissions, and managing workforce talent.... ...position offers flexible work with remote options. #J-18808-Ljbffr...Remote workFlexible hours$189k - $325.45k
...Director, Global Regulatory Leader Johnson & Johnson Innovative Medicine R&D is recruiting... ..., NJ; or Raritan, NJ. Remote work options may be... ...regulatory requirements, CMC considerations, commercial... ...Perform critical review of submission documents to ensure compliance...Remote workTemporary workLocal area- ...US ProPharma Group, LLC is seeking a Director, Regulatory Affairs for a remote role. The successful candidate will define and execute global CMC regulatory strategies critical to the... ...focused on compliance and regulatory submissions. Responsibilities include leading CMC...Remote workContract workFor contractors
$177k - $278.08k
...This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...aspects of global registrational submissions of complex drug product or suite... ...Takeda's Hybrid and Remote Work policy. #LI-Hybrid...Remote workMinimum wageTemporary workLocal areaImmediate startWorldwide$176.4k - $228.25k
...Neura Market is seeking a Manager/Director of CMC Regulatory Affairs to lead the development and implementation... ...research and ensuring compliance with global regulatory standards. The ideal... ...skills. This position allows for remote work but regular on-site visits are required...Remote work$177k - $278.08k
.... This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...of global registrational submissions of complex drug product or suite... ...following Takeda's Hybrid and Remote Work policy. #LI-Hybrid...Remote workMinimum wageFull timeTemporary workLocal areaWorldwide$148.5k - $257.4k
...around the world. We are a global healthcare leader headquartered in... ...tactical and operational regulatory CMC leadership across therapeutic... ...registrations, and post approval submissions. This is accomplished through... ...: Indianapolis, IN. A remote option may be considered....Remote workFull timeRelocation packageFlexible hours- ...worldwide. As Executive Director, Global Regulatory Affairs CMC Early Development you... ...Serve as an influential leader internally and externally... ...regulatory strategy and key submissions/health authority... ...hybrid" following Takeda's Hybrid and Remote Work policy....Remote workWorldwide
$238k - $374k
...worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination... ...Serve as an influential leader internally and externally... ...strategy and major submissions for an assigned portfolio... ...Takeda's Hybrid and Remote Work policy. Compensation...Remote workTemporary workWork at officeLocal areaWorldwide- ...Merck & Co. is seeking a Senior Principal Scientist (Sr. Director level) in Regulatory Affairs CMC, focused on dry powder inhaler combination products.... ...Benefits include a comprehensive package and a potential remote work option for qualified candidates. #J-18808-Ljbffr...Remote work
$169.5k - $248.6k
...around the world. We are a global healthcare leader headquartered in... ...The purpose of the Senior Director, Global Regulatory Affairs, Global Regulatory... ...GRA central functions, GRA-CMC, GRA-Devices, and regional... ...programs, the GRL leads the US submissions and agency interactions....Remote workFull timeLocal areaFlexible hours$160k - $196k
...right way. Job Title: Associate Director Regulatory Operations Global Submission Mgmt Location: [Conshohocken,... ...teams including Regulatory Strategy, CMC, Clinical, Labeling, and vendors to... ...arrangements, including hybrid and remote options. Madrigal's Total...Remote workMinimum wageFull timeLocal areaFlexible hours- ...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...
- ...Recursion is seeking an Associate Director of CMC Regulatory Affairs to lead the development and... ...regulatory affairs, providing high-quality submissions for global clinical trials. Ideal candidates... ...Salt Lake City, with options for remote work. A competitive salary range...Remote work
$137k - $215.27k
...This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...development of robust and accurate submissions. Develops constructive... ...following Takedas Hybrid and Remote Work policy. #LI-Hybrid...Remote workMinimum wageFull timeTemporary workLocal areaImmediate startWorldwide$212k - $333.19k
...worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-... ...implementation. Globally influences and... ...as a key opinion leader and resource within... ...global regulatory submissions (e.g., Core Dossiers... ...Takeda's Hybrid and Remote Work policy. #LI-...Remote workMinimum wageTemporary workLocal areaWorldwideNight shift$258.68k - $313.46k
...Senior Director, Global Regulatory Strategy, Neuroscience This role will require... ...product managers (submissions) and regulatory operations... ...key areas Drug Development/CMC/Pharmtox/Biopharmaceutics/Clinical... ...capability centers. Employees in remote-by-design or lab-based...Remote workHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work- ...Neurocrine Biosciences in San Diego, California is seeking a Regulatory Affairs professional to lead CMC regulatory strategy and ensure compliance for... ...communication, the role entails managing regulatory submissions to enable early approvals. The ideal candidate will possess...
$142.5k - $256.5k
...The Role: The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC activities for one or more products... ...implement effective CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks Provide...Permanent employmentWork at officeWork from home$155.68k - $202.38k
QuidelOrtho seeks a Senior Manager of Regulatory Affairs to lead and support regulatory strategies for the Transfusion Medicine Business... ...specifically in regulatory strategy for product development. This remote eligible position prefers candidates from Raritan, NJ;...Remote work$174.5k - $274.23k
...develops and leads global strategies to maximize global regulatory success towards... ...requirements. Is a leader both in the department... ...: The Director will be responsible... ...Accountable for all US FDA submissions and approvals of... ...Takeda’s Hybrid and Remote Work policy....Remote workMinimum wageFull timeTemporary workLocal area$212k - $333.19k
...worldwide. Join Takeda as a Senior Director, Global Regulatory Lead – Oncology, where you will be... ...timely manner. Accountable for US FDA submissions and approvals of project(s) of... ...hybrid following Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI-AA1...Remote workMinimum wageTemporary workLocal areaImmediate startWorldwide$176k - $236k
...Director, Global Regulatory Lead page is loaded## Director, Global Regulatory Leadlocations: Remote (US)time type: Full timeposted on: Posted Todayjob requisition id: R33135BeOne... ...corporate goals.* Supports the preparation and submission of global regulatory documentation to...Remote workHourly payTemporary workWork experience placementShift work$137k - $215.27k
...looking for a professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory CMC or Device... ...Responsibilities include executing regulatory strategies and managing submissions. The position offers a hybrid work model, with a salary...- ...Moderna Therapeutics in Norwood, MA is seeking a Regulatory CMC Lead to manage a team of CMC experts. This role involves overseeing regulatory strategies for a portfolio of products, ensuring compliance with health authority guidelines, and leading interactions with regulators...
- ...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...
$130.8k - $209.4k
...Work with exceptional global teams on a broad pipeline... ...with program goals, regulatory expectations, and... ...sections for regulatory submissions, responses, and technical... ...at the Moderna site. Remote work is not eligible.... ...working in cross‑functional CMC teams within a...Remote workPermanent employmentFull time- ...Brunel is recruiting a Director, Regulatory Affairs CMC – Biologics to provide strategic leadership across... ...full-time opportunity is fully remote, aimed at experienced professionals... ...ideal candidate will lead complex global submissions and mentor teams, contributing to high...Remote workFull time
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