Regulatory Affairs Director - Global Drug Development
Noema Pharma
Noema Pharma in Massachusetts is seeking a Director of Regulatory Affairs to lead regulatory strategy and execution across clinical programs, reporting to SVP Regulatory Affairs. You will drive IND/NDA submissions, interact with FDA, and build regulatory capabilities across multinational teams to accelerate development and access to breakthrough therapies. The role demands extensive regulatory leadership, strong communication, and collaboration with program teams; travel to Boston monthly is #J-18808-Ljbffr Noema Pharma
$238k - $374k
...bring life-changing therapies to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you will provide strategic leadership and development to global regulatory subject matter experts to ensure innovative...SuggestedMinimum wageTemporary workWork at officeLocal areaRemote workWorldwide$196.7k - $353.4k
The RoleModerna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader... ...with regulatory procedures and legislation for drug development, product registration, line extension and...SuggestedPermanent employmentFull timeWork at officeWork from home- ...strategic and operational QA oversight across drug development, manufacturing, and commercialization. You... ...QMS and governance, collaborate with CMC, Regulatory, Clinical Operations, and Supply Chain, and ensure compliance with global regulations to protect patient safety and...Suggested
$142.5k - $256.5k
The Role The Associate Director, Global Regulatory Advertising and Promotion will... ...liaison between Regulatory Affairs, Legal, Medical, and Commercial... ...(Office of Prescription Drug Promotion)/Advertising and... ...during early stages of product development. Maintain up-to-date...SuggestedPermanent employmentWork at office$177k - $278.08k
...patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing &... ...registrational submissions of complex drug product or suite of products is... ...contributes to Regulatory, Pharmaceutical Development, and Commercial project teams throughout...SuggestedMinimum wageTemporary workLocal areaRemote workWorldwide$177k - $278.08k
...therapies to patients worldwide.The Director Global Regulatory Affairs, Neuroscience is responsible for developing... ...regulatory guidance for the global development of various products within the... ...submissions. Solid working knowledge of drug development process and regulatory...Minimum wageTemporary workLocal areaRemote workWorldwide$232.5k - $335.83k
...Strategy and Management Office, Global Clinical DevelopmentLocation:... ...within our Global Clinical Development team, you'll lead the... ...mitigation strategies, internal and regulatory audit readiness, training and... ...that engages patients early in drug development and uses their...Full timeWork at office$238k - $374k
...knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking... ...Global Regulatory Affairs CMC Early Development (GRA CMC ED).Here, everyone matters... ...development, analytical, formulation, drug substance/drug product, device/combination...Minimum wageTemporary workLocal areaRemote work$248k - $280k
...Stoke’s first medicine in development, zorevunersen, has demonstrated... ...Position Purpose: The Director, Global Regulatory Strategy will be responsible... ...years minimum of Regulatory Affairs experience in the pharmaceutical... ...Experience in rare disease drug development preferred and...Temporary work$212k - $318k
...represented in commercial and development plans across the... ...than ever before.The Director, T1D will serve as a T... ...CGT) portfolio in the Global Value and Access... ...International P&R, Corporate Affairs, US Managed Markets,... ...commercialization and drug developmentCell and Gene...Full timeSummer workRemote workFlexible hours2 days per week$145k - $215k
...Therapeutics is seeking a Senior Manager, Regulatory Affairs to serve as a key regulatory... ...leader across multiple drug development programs. Reporting to the Director of Regulatory Affairs, the Senior... ...requirements; familiarity with global regulatory frameworks a plus....$195k - $330k
...How you’ll make an impact:Lead the development and execution of global regulatory CMC strategies for degrader programs... ....Scale and lead the Regulatory Affairs CMC function as the pipeline and organization... ...direct work on small molecule drug substance and drug product...$167k - $300.7k
...Moderna, Inc. is seeking a Director of Regulatory Strategy to support select... ...a strategic leader within Global Regulatory Science, responsible... ...with therapeutics development is preferred. Here’s What You... ...procedures and legislation for drug development, product registration...Permanent employmentWork at officeWork from home$70 - $75 per hour
...Regulatory Affairs Manager / Senior ManagerThis role supports global regulatory activities for innovative development programs within a dynamic biopharma environment... ...to the Senior Director of Regulatory Affairs,... ...regulatory requirements for drug development.Hands-on experience...Contract workTemporary workWork at officeLocal areaMonday to Friday- Treeline in the United States is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and ensure compliance with applicable laws and guidelines. This hands-on role will influence regulatory strategy, prepare and...
- ...X and YouTube. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory... ...compounds through all phases of development, including post approval and... ...Demonstrates excellent understanding of drug development and leadership behaviors...Worldwide
- ...in Cambridge, MA is seeking a motivated regulatory professional to join their dynamic team... ...regulatory strategies and manage global submissions including IND, CTA, NDA, and... ...S./M.S. with 2+ years of experience in drug development and regulatory submissions. Join a passionate...
- ...Incorporated in Boston, MA, is seeking a Regulatory Strategy Associate Director to oversee the global regulatory strategy for development programs and marketed products. The ideal... ...have a strong understanding of regulatory affairs frameworks and a minimum of 8 years...
- Discover International is seeking an Associate Director or Director to lead Global Regulatory Affairs on an initial contract. You will drive regulatory strategy... ...interactions and manage submissions for multiple development programs, with potential conversion to permanent...Remote jobPermanent employmentContract work
- AstraZeneca GmbH is seeking a Regulatory Affairs Director to provide strategic regulatory leadership within their Cardiovascular, Renal... ...with health authorities, and contribute to the development of a diverse drug pipeline. The ideal candidate will have an advanced degree...
$208.2k - $327.14k
Overview Head of Global Regulatory Affairs Operations, Compliance & Process Excellence (Senior Director) - role at BioSpace, as described in the job posting. The Plasma-... ...Demonstrated knowledge and understanding of global drug development and interface with commercial...Full timeRemote workFlexible hours- Associate Director, Global Regulatory Affairs, Advertising and Promotion Job Description At Takeda, we are a forward‑looking, world‑class R&D organization... ...Process (CMRP). Provide regulatory guidance during development, review, approval, and implementation of medical and...Full timeRemote workWorldwide
- ...Head of Global Regulatory Advertising and Promotion About the Company Industry shaping biopharmaceutical company Industry Biotechnology... ...of Global Regulatory Advertising and Promotion to lead the development and execution of the global regulatory strategy for...
- # Director, Portfolio Strategy - Global InitiativesFlagship PioneeringDirectorVenture CapitalHealthcare, Biotech & Life SciencesFull-timeLocationCambridge... ...R&D portfolio from early discovery through clinical development and commercialization readiness.The role partners...
- Vertex Pharmaceuticals is seeking an Associate Director, Global Submission Management in Boston to lead a portfolio of global regulatory submissions across development and lifecycle programs, including Pulmonary or Cell & Gene Therapy areas. You will partner with Global...
- ...system. Noema’s research and development is focused on... ...novel therapies. Tasks The Director of Regulatory Affairs provides strategic and operational... ...compliant development of new drug programs. Partner with... ...support of ongoing and future global clinical studies. Review...Work at officeLocal area
$177k - $260k
## Director, US Regulatory Advertising & Promotion (Remote)Applylocations... ...Ipsen is a mid-sized global biopharmaceutical... ...nearly 100 years of development experience, with... ...Commercial Regulatory Affairs will report to the Sr... ...Office of Product and Drug Promotion pertinent to...Remote jobTemporary workWork at office- ...seeking an Associate Director of Regulatory Strategy to support programs... ...in the US and other global markets.... ...regulatory lead delegate for development compounds in the... ..., INDs, CTAs, orphan drug designations, pediatric... ...serve as regulatory affairs representative to provide...
- A health technology company in Cambridge, MA is seeking a Global Product Manager for Mobile Applications. The role involves defining product strategy, leading global initiatives, and collaborating with cross-functional teams to drive product success. Candidates should...Work at office
- Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global... ...product/business strategy development Skills and qualifications:... ...knowledge in regulatory affairs Strong strategic planner with... .... Expert knowledge of drug development process and regulatory...Full timeLocal area
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