Head of Regulatory Affairs — Global Submissions & Strategy
Noema Pharma AG
Noema Pharma AG in the Boston area is seeking a Director of Regulatory Affairs to provide strategic and operational leadership across development and commercialization programs. You will shape regulatory strategy and lead submissions for INDs, NDAs, MAAs and related supplements while coordinating with cross-functional teams. This senior role involves direct interaction with FDA and other health authorities, organizing meetings, managing risk assessments, ensuring trial disclosure compliance, and #J-18808-Ljbffr Noema Pharma AG
$196.7k - $353.4k
...seeking a Sr. Director of Regulatory Strategy to support oncology programs... ...strategic leader within Regulatory Affairs, responsible for developing... ...clear and compelling global regulatory strategies,... ...accountability for regulatory submissions and related supplements and...SuggestedPermanent employmentFull timeWork at officeWork from home- ...Copenhagen, Denmark Reporting to : VP, Regulatory Affairs & Quality About Hemab Hemab... ...Affairs, you'll shape and deliver global regulatory strategy for Hemab's development programs in... ...for high-quality regulatory submissions and approvals, working with Hemab colleagues...SuggestedRemote work
- ...in Cambridge, MA is seeking a Director of Regulatory Affairs - Labeling. This high-visibility role shapes global labeling strategy and partners cross-functionally to ensure... ...stakeholders, oversee USPI/CCDS labeling, manage SPL submissions, and drive lifecycle labeling from...SuggestedWork at officeRelocation
- ...Takeda in Boston, MA is seeking a Director of Global Regulatory Affairs, Neuroscience to lead global regulatory strategy across multiple projects, oversee GRTs, and... ...guide cross‑functional teams toward successful submissions. You will manage US FDA submissions,...Suggested
- ...company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership... ...The candidate will prepare regulatory submissions, interact with health authorities like... ...role is vital for supporting ongoing global clinical studies. #J-18808-Ljbffr...Suggested
- ...AstraZeneca seeks a seasoned Regulatory Leader to guide strategic... ...and collaborate with global teams to shape regulatory strategies and compliance. With 6+ years in regulatory affairs, you will oversee risk assessments... ..., and ensure timely submissions while aligning with...Local area
- Pulpdent Corporation in Watertown, MA, seeks a Head of Regulatory Affairs to guide global regulatory strategy across R&D, manufacturing, and marketing. Lead a high-performing team, manage FDA submissions, and ensure compliance with EU MDR and ISO 13485. This on-site role...Worldwide
- AbbVie in Cambridge, MA, seeks a Director Regulatory Affairs Global Regulatory Lead (GRL II) for... ...Neuroscience. You will develop global regulatory strategies, lead the GRPT, oversee dossier development, and ensure compliant submissions across US, EU, and other regions. You...
- ...Biotechnologies is seeking a Director of Regulatory Affairs to lead regulatory strategy across its portfolio, spanning... ...programs. You will serve as the global regulatory lead and primary... ...FDA and other authorities, guiding submissions, agency meetings, and data narratives...
- ...Director, Regulatory Affairs, Global Labeling Strategy (US) Overview The Director of Global Labeling (GL) US will play a lead role in building and... ...Technology and Operations, and Supply Chain to ensure submission-ready labeling components comply with regulatory...Local area
$177k - $278.08k
...worldwide.Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the... ....Labeling Documents Authoring, Submission, and Labeling Negotiations Independently... ...clinical, safety, medical affairs, and commercial, to ensure unparalleled...Minimum wageLocal areaRemote workWorldwide$150k - $275k
...Global Regulatory Head Position Summary The Global Regulatory Head directs the regulatory strategy and submissions for the company's RLT portfolio, ensuring compliance with international... ...to the CMO or VP of Regulatory Affairs, it requires deep knowledge of global...Local area$200k - $265k
...an unparalleled, direct impact.The OpportunityLeads the global regulatory strategy, submission planning, and health authority engagement for... ...agreed timelines. Accountable for the Global Regulatory Affairs team supporting nemolizumab and for driving successful...Full timeTemporary workWork experience placementWork at officeWorldwide- ...AstraZeneca plc in Cambridge, MA, invites you to shape regulatory strategy across development, commercialization and life... .... The role emphasizes collaboration across global, regional, and local regulatory affairs, coaching staff, and staying ahead of evolving laws...Local area
- ...Olema Oncology seeks a Director, Global Regulatory Strategy Lead to guide innovative regulatory strategies... ...lead cross-functional teams, oversee submissions (INDs, NDA/BLA), and partner with... ...You will mentor a growing Regulatory Affairs group, ensure regulatory compliance,...
$182k - $346k
...and YouTube. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy (Neuroscience), is responsible for developing... ...under the direction of a GRS Sr GRL or TA Head. May participate in or lead regulatory and Company...Worldwide- ...Hemab Therapeutics in Cambridge, MA is seeking a Director, Regulatory Affairs to shape and deliver global regulatory strategy for our rare bleeding disorder programs. You will sit close to science and development teams, turning complex data into clear regulatory choices...Remote work
$180k - $245k
...experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our... ...and executing regulatory strategies that support global product development... ...expectations.Lead the preparation, submission, and maintenance of regulatory...$230k - $250k
...Director, Global Regulatory Affairs - Strategy Lead Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the... ...tactical guidance and lead the development of regulatory submissions (INDs, CTx, briefing documents, IB, NDA, BLA, DMF, IMPD...Work at officeFlexible hours2 days per week- Pulpdent Corporation is seeking a Head of Regulatory Affairs to lead global regulatory strategy across the full product lifecycle. You will ensure compliance with domestic and international requirements and partner with R&D, manufacturing, and marketing to drive growth...
- Discover International is seeking a Director, Global Regulatory Affairs — Oncology to lead regulatory strategy and execution for oncology programs. You will partner... ...development teams to navigate milestones, submissions, and lifecycle activities. The ideal candidate has...
- Spryte Medical seeks a Director of Regulatory Affairs to guide global regulatory strategy for a portfolio of neurovascular imaging devices. You will lead cross‑functional teams, manage complex submissions, and oversee external regulators to accelerate market access. The...
- ...Centessa Pharmaceuticals is seeking a Senior Director, Regulatory CMC in the US to provide strategic and operational leadership for... ...molecule programs. You will drive regulatory readiness, oversee submissions, and manage external partners to enable timely registrations....
- ...Boston, MA is seeking a Director Regulatory Site CMC to lead site-... ...change management and regulatory submissions across small molecule and... ...in biopharma with deep global HA regulatory experience, an... ...ability to communicate regulatory strategy to cross-functional teams....
- ...Smithsonian Astrophysical Observatory in Cambridge, MA, seeks a Director of Human Resources to lead HR strategy, modernization, and compliance onsite. You will manage Federal and non-Federal (Trust) hiring, immigration programs, and HR analytics across SAO sites, advancing...
- ...seeks an accomplished Senior Vice President of Regulatory Affairs and Quality to lead global regulatory strategy and product quality for the company's small molecule... ...high-performing team dedicated to timely, compliant submissions and lifecycle management. #J-18808-Ljbffr
- Repertoire Immune Medicines is seeking an experienced Director of Regulatory Affairs to lead global regulatory strategy for Phase 1/2 oncology programs, based in Watertown, MA with in-office presence at least 3 days a week. The role will own INDs/CTAs, health authority...Work at office3 days per week
- Ipsen Biopharmaceuticals Inc. seeks an Associate Director, Global Regulatory Affairs to lead regulatory strategies for development and marketed products across regions. The role interfaces with R&D, Franchise, and Commercial Ops, ensuring compliant, efficient execution...
$196.7k - $353.4k
...seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy... ...unprecedented new drug modality globally. The Sr. Director will be a... ...for regulatory submissions and related supplements and... ...overall plans to Regulatory Affairs the Project Team and senior...Permanent employmentFull timeWork at officeWork from home- ...Summary The Head of Regulatory Affairs leads ARTBIO’s regulatory function for... ...programs, ensuring clear strategy, compliant execution, and... ...Responsibilities Define and lead global regulatory strategy for... .... Lead key regulatory submissions, including INDs, CTAs, and...
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