Global Regulatory Strategy Director — Gene Therapy
Arbor-Biotechnologies-Inc
Arbor Biotechnologies is seeking a Director of Regulatory Affairs to lead regulatory strategy across its portfolio, spanning preclinical and early clinical programs. You will serve as the global regulatory lead and primary contact with FDA and other authorities, guiding submissions, agency meetings, and data narratives. The role requires a minimum of 10 years in biotech/pharma development with regulatory experience, strong communication, and collaboration with internal and external partners. #J-18808-Ljbffr Arbor-Biotechnologies-Inc
$212k - $318k
...for Cystic Fibrosis (CF), Casgevy, a gene therapy for sickle cell disease and beta-... ...patients faster than ever before.The Director, T1D will serve as a T1D Market... ...Gene Therapy (CGT) portfolio in the Global Value and Access Strategy (GVAS) team.The individual will be...SuggestedFull timeSummer workRemote workFlexible hours2 days per week$268.2k - $402.2k
Job DescriptionGeneral Summary:The Executive Director, Regulatory Strategy will serve as a seasoned regulatory leader with expert technical and tactical... ...the development and implementation of innovative global regulatory strategies for product development and commercialization...SuggestedFull timeSummer workLocal areaRemote workFlexible hours2 days per week- ...Moderna Therapeutics in Cambridge seeks a Sr. Director of Regulatory Strategy to lead global regulatory plans for oncology programs, guiding filings and interactions with health authorities. This newly created role demands strategic vision, deep regulatory knowledge,...Suggested
- Takeda is looking for a Director, Global Regulatory Lead Oncology in Boston, MA. This role encompasses setting the global regulatory strategy and overseeing all regulatory activities for high-impact oncology programs. You will collaborate with cross-functional teams to...Suggested
- Moderna, Inc. is seeking a Director of Regulatory Strategy to lead global regulatory plans for assigned programs in rare, autoimmune and oncology portfolios. You will shape strategy, communicate risks and opportunities, and negotiate with health authorities in the US and...Suggested
- Sana Biotechnology, Inc. is seeking a Senior Director to lead the company’s IP strategy in cell and gene therapy. You will draft and prosecute patents, manage global portfolios, and guide landscape analyses. Collaboration with R&D and external counsel is essential to align...
- AstraZeneca GmbH is seeking a Strategy and Commercial Executive Director for Cell Therapy Strategy and Commercial. You will shape end-to-end strategy across a defined indication, lead global commercial initiatives, and partner with Therapeutic Areas on clinical strategy...
- Genetix Biotherapeutics is looking for a Director, Regulatory CMC to lead global regulatory strategies for gene therapy products. This full-time hybrid position based in Somerville, Massachusetts involves managing post-approval regulatory strategies and ensuring compliance...Full time
$150k - $180k
...vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able to... ...which makes everything possible.The Global Strategic Account Director is responsible for growth and expansion... ...What you will do:Develop and lead strategy, partnerships and teams supporting...Full timeRemote workNight shift- ...United States is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and ensure compliance with applicable... .... This hands-on role will influence regulatory strategy, prepare and manage submissions, and navigate...
- A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing... ...communication and leadership skills. This role is vital for supporting ongoing global clinical studies. #J-18808-Ljbffr Noema Pharma AG
- Treeline Biosciences in Watertown, MA is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities, shape strategy, and manage submissions across INDs, NDAs, and BLAs. The role requires 8+ years in regulatory affairs...
$177k - $278.08k
...innovation and delivers transformative therapies to patients. By focusing R&D efforts... ...therapies to patients worldwide.The Director Global Regulatory Affairs, Neuroscience is responsible... ...developing innovative global regulatory strategies and providing strategic regulatory...Minimum wageTemporary workLocal areaRemote workWorldwide$177k - $278.08k
...innovation and delivers transformative therapies to patients. By focusing R&D efforts... ...patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing... ...develops the regulatory CMC strategy and leads the execution of regulatory...Minimum wageTemporary workLocal areaRemote workWorldwide$238k - $374k
...innovation and delivers transformative therapies to patients. By focusing R&D efforts... ...to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device... ...innovative and robust regulatory strategies for medical devices and drug-device...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide$186.23k - $279.35k
...about science and experienced within regulatory affairs and drug development? Do you... ...affairs to get involved in the global regulatory strategies and support the research, development... ...the business. The Regulatory Affairs Director (RAD) provides strategic and operational...Hourly payFull timeTemporary workWorldwide3 days per week$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica, CAIntroduction to role: Are you ready to set the global regulatory vision for pioneering cell therapies and turn breakthrough...Hourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$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 will shape regulatory pathways for novel, first-in-class therapeutics and drive successful global development and...Permanent employmentFull timeWork at officeWork from home$196.7k - $353.4k
The Role:Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology programs to be based in its Cambridge headquarters... ..., will be relied on to articulate clear and compelling global regulatory strategies, highlighting risks and...Permanent employmentFull timeWork at officeWork from home$230k - $330k
...Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed... ...Lead supplier segmentation, category strategies, and preferred supplier frameworks.... ...reach more patients and developing novel therapies for other rare neuroendocrine diseases,...Full timeWork at office$200k - $265k
...opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.The OpportunityLeads the global regulatory strategy, submission planning, and health authority engagement for Nemolizumab across all approved and development-stage...Full timeTemporary workWork experience placementWork at officeWorldwide$196.7k - $353.4k
The Role Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology programs to be based in its Cambridge headquarters... ..., will be relied on to articulate clear and compelling global regulatory strategies, highlighting risks and...Permanent employmentWork at officeLocal areaWork from home- ...experienced labeling professional to join our labeling strategy team. This team is responsible for developing... ...or Philadelphia, PA Key Responsibilities Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional product, development...Local area
- Akebia Therapeutics 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 labeling complies with FDA and global requirements. You will influence senior...Work at officeRelocation
- ...Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy is responsible for developing and implementing global strategies to secure and maintain...Temporary workWorldwide
- Noema Pharma in Massachusetts is seeking a Director of Regulatory Affairs to lead regulatory strategy and execution across clinical programs, reporting to SVP... ...accelerate development and access to breakthrough therapies. The role demands extensive regulatory leadership,...
$168k - $252k
Job DescriptionGeneral Summary:The Regulatory Strategy Associate Director will be responsible for overseeing the development of regional or global regulatory strategy for development programs or marketed products. This role will serve as a global regulatory lead, or in...Full timeSummer workRemote workFlexible hours2 days per week$227.2k - $340.8k
...patients. We are looking for a Senior Director - AI Transformation Program Strategy to help prioritize and coordinate... .... Company Information Vertex is a global biotechnology company that invests... ...pipeline of investigational therapies across a range of modalities in other...Summer workRemote workFlexible hoursShift work2 days per week$100k - $200k
..., helping life sciences companies bring therapies to patients faster. As one of the fastest... ...sales and product adoption.As the Global Program Manager, you will own customer success... ...resultsExperience in technology strategy and roadmap development for large pharma...Contract workWork at officeLocal areaRemote workWork from homeHome office3 days per week- Overview Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the oncology franchise in one of... ...vaccines based on messenger RNA technology in the US and other global markets. Responsibilities Serve as the global...
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