Remote Director, Regulatory CMC - Global Submissions Leader
Immuneering Corporation
Cambridge, MA
- Remote job
Immuneering Corporation in Cambridge, MA seeks a Director of Regulatory CMC to lead global CMC regulatory strategies for investigational and commercial products. You will prepare and submit CMC sections for INDs, NDAs, and other filings, interfacing with FDA/EMA and cross-functional teams. The ideal candidate has 10+ years in CMC regulatory affairs, deep FDA/EMA knowledge, and strong leadership and project-management skills. #J-18808-Ljbffr Immuneering Corporation
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Remote Director, Regulatory CMC - Global Submissions Leader in Cambridge, MA vacancy
$177k - $278.08k
...worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization,... ...of global registrational submissions of complex drug product or suite... ...Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1...Remote workMinimum wageTemporary 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 workRelocation packageFlexible hours$238k - $374k
...patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device... ....Serve as an influential leader internally and externally... ...strategy and major submissions for an assigned portfolio... ...following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI...Remote workMinimum wageTemporary workWork at officeLocal areaWorldwide$238k - $374k
...Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you... ...regulatory strategies and submissions for small molecule and biologic... ...Serves as an influential leader internally and externally... ...with Takeda’s Hybrid and Remote Work policyTakeda...Remote workMinimum wageTemporary workLocal area- Kardigan is seeking a Senior Director, CMC Regulatory to lead regulatory strategies and interactions for late-stage programs focused on cardiovascular... ...extensive experience with FDA, EMA, and ICH guidelines, plus a track record of successful global #J-18808-Ljbffr Socket.devSuggested
- ...Pharmaceuticals, Inc. in South San Francisco, CA, is seeking a Director of Regulatory Affairs CMC to lead global regulatory strategies for small molecule programs... ...Clinical and Operations to ensure timely, compliant submissions and lifecycle activities, with risk mitigation and...
- ...Companies is seeking a Senior Director, Quality & CMC Regulatory Strategy to join a global regulatory consulting and clinical development services leader. This remote permanent role places you as a... ...pharmaceutical clients, guiding global submission strategies and CMC regulatory...Remote jobPermanent employment
- Marea Therapeutics seeks a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions for the manufacturing of our products in the US and globally. The incumbent will oversee Regulatory CMC aspects of product...
$258.68k - $313.46k
...bms.com/working-with-us.Sr Director, Global Regulatory Strategy, NeuroscienceWill... ...regulatory product managers (submissions) and regulatory operations... ...key areas – Drug Development/CMC/Pharmtox/Biopharmaceutics/... ...centers. Employees in remote-by-design or lab-based roles...Remote workHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work$194k - $199k
...Therapeutics, Inc. is seeking an experienced Associate Director of Regulatory Affairs, CMC to coordinate global regulatory filings. This role requires a Bachelor'... ...on managing CMC regulatory aspects and preparing submissions. The salary range for this position is...Work at office- ...better. Chiesi Global Rare Diseases Chiesi... ...with global leaders in scientific... ...Currently seeking a Regulatory Affairs (RA)... ...with strong CMC pre and post approval... ...broad range of submissions to Regulatory... ...and Senior Director or Reg CMC Lead... ...arrangements, remote work options, and...Remote workHourly payWork at officeLocal areaWorldwideRelocation packageFlexible hours
$177k - $278.08k
...patients worldwide.Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part... ...global regulatory strategy and lead major submissions for high-impact oncology programs.How... ..." following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1Takeda Compensation...Remote workMinimum wageTemporary workLocal areaWorldwide- Position SummaryThe Director, Global Regulatory Strategy- Oncology is responsible... ...recommendations clearly to senior leaders, health authorities, and... ...and key meetings. Remote-first candidates may be considered... ..., Commercial, Statistics, CMC, and other R&D functions.Experience...Remote workFull timeLocal area
- ...focusing on allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. The Manager, Regulatory Affairs will lead global CMC regulatory strategy and submissions to accelerate clinical and product development. The role requires onsite work with a minimum...Work at office3 days per week
$240k - $275k
...Diego, CAClinical - Regulatory /Full-Time /HybridThe Senior Director, Global Regulatory Affairs... ...-on regulatory leader with deep experience... ...Clinical, CMC, Biometrics, and Translational... ...(CTR) and CTA submissions.Serve as the... ...San Diego office. Remote permitted upon approval...Remote workFull timeSummer workWork at officeRelocationRelocation packageShift work$246.98k - $299.29k
...com/working-with-us.The GRS-CMC Director is responsible for... ...strategic direction based on global regulatory guidelines and experience.... ...oversee preparation of CMC submissions while ensuring thoroughness... ...capability centers. Employees in remote-by-design or lab-based roles...Remote workHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaFlexible hoursShift work- ...Corporation is seeking a Senior Manager CMC Regulatory Affairs to oversee global CMC regulatory strategies for... ...marketing applications. The role is remote and emphasizes collaboration with various... ...and strong expertise in regulatory submissions. Competitive salary and...Remote job
$177k - $278.08k
Job Description Director, Global Regulatory Lead Oncology - responsible for setting global regulatory strategy and leading major submissions for high‑impact oncology programs. About the role... ...hybrid” following Takeda’s Hybrid and Remote Work policy. #J-18808-Ljbffr...Remote workTemporary workLocal area$148.5k - $257.4k
...provides strategic, tactical, and operational regulatory CMC leadership across advanced therapeutic... ...applications, market registrations, and post-approval submissions. This is accomplished through a strong working knowledge of global regulations, guidelines, and regulatory...Flexible hours- ...Director, Regulatory CMC Join Acadia as the Director, Regulatory... ...develop and execute global regulatory CMC strategies... ...and amendments for submission to regulatory... ...influencing senior level leaders regarding matters of... ...working independently from remote locations. The...Remote workWork at officeWorldwideNight shift
ACADIA Pharmaceuticals
San Diego, CA1 day ago - Incyte Corporation seeks an experienced Regulatory CMC professional to manage submissions and strategy for development and marketed products, spanning small... ...post-approval. The role requires liaising with FDA and global authorities, ensuring compliant, high-quality...
$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 risksProvide...Permanent employmentFull timeWork at officeWork from home- Recursion, a clinical‑stage TechBio company, seeks a Director CMC Regulatory Affairs to lead regulatory strategy for small molecule programs... ...CMC documents (Module 2/3, IMPD) and decisive regulatory submissions. This role emphasizes strategic leadership, fast‑paced timelines...Remote job
$207.5k - $255.2k
...implementation of CMC regulatory strategy for... ...investigational drugs in global Phase 1-3... ...practices for CMC submissions and meetings. Strategize... ...You’ll Join As Director CMC Regulatory... ...Compensation: This role is remote-friendly, with... ...and autonomy—leaders take...Remote workWork at officeLocal areaWork from homeWorldwide- A biotechnology company in Seattle is seeking a Director/Sr. Director for Regulatory Affairs focused on CMC. This role involves developing strategies, managing... ...agencies, and ensuring compliance with submission standards. Ideal candidates will have 7+ years in...
- Taiho Oncology, Inc. seeks a senior Director to lead global regulatory CMC activities, coordinating strategy, submissions, and approvals across US, EU, and other regions. This role partners with internal teams and external consultants to ensure compliant development and...
- ...Responsibilities The Director/Senior Director, Regulatory CMC (Chemistry, Manufacturing... ...• Develop and lead global CMC regulatory strategies... ...products to ensure timely submissions and approvals. • Prepare... ...benefits. Fully remote work environment with a flexible...Remote workFlexible hours
IMMUNEERING CORPORATION
San Diego, CA4 days ago $189.7k - $237.1k
...Summary Join Acadia as the Director, Regulatory CMC and play a critical... ...develop and execute global regulatory CMC... ...MAAs and amendments for submission to regulatory authorities... ...senior level leaders regarding matters of... ...working independently from remote locations. The employee...Remote workWork at officeLocal areaWorldwideNight shift3 days per week- Moderna is seeking an Associate Director, Global Regulatory-CMC to lead global regulatory CMC strategies and coordinate submissions across development stages. You will guide product teams, manage health authority interactions, and drive timely CMC approval while aligning...
- Moderna is seeking a Global Regulatory CMC Lead to coordinate CMC activities across product lifecycles and develop global regulatory strategies... ..., strong collaboration skills, and the ability to drive submissions through health authorities while maintaining alignment with...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Remote Director, Regulatory CMC - Global Submissions Leader. Be the first to apply!
Related searches
- quality regulatory manager Cambridge, MA
- regulatory & compliance manager Cambridge, MA
- director global regulatory affairs Cambridge, MA
- head compliance Cambridge, MA
- senior director regulatory affairs Cambridge, MA
- associate director compliance Cambridge, MA
- compliance manager Cambridge, MA
- regulatory affairs director Cambridge, MA
- regulatory cmc manager Cambridge, MA
- regulatory affairs manager pharmaceutical Cambridge, MA