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
## Executive Director, Regulatory Strategy, Cell & Gene TherapyApplylocations: Boston, MA: Washington, DCtime type... ...and implementation of innovative global regulatory strategies for product development... ...pipeline of investigational therapies across a range of modalities in...SuggestedSummer workLocal areaRemote workFlexible hours2 days per week$177k - $278.08k
...that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic... ...therapies to patients worldwide.Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and...SuggestedMinimum wageLocal areaRemote workWorldwide- AstraZeneca plc in Cambridge, MA, invites you to shape regulatory strategy across development, commercialization and life cycle management.... ...ensuring compliance. The role emphasizes collaboration across global, regional, and local regulatory affairs, coaching staff, and...SuggestedLocal area
- Discover International is seeking a Director, Global Regulatory Affairs — Oncology to lead regulatory strategy and execution for oncology programs. You will partner with global clinical development teams to navigate milestones, submissions, and lifecycle activities. The...Suggested
- 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...
- AstraZeneca seeks a seasoned Regulatory Leader to guide strategic regulatory activities across development, launch, and... ...You will influence authorities and collaborate with global teams to shape regulatory strategies and compliance. With 6+ years in regulatory affairs,...Local area
- Amgen seeks an Associate Regulatory Affairs Director to oversee cell therapy regulatory strategy and submissions across global regions. You will partner with senior teams to advance innovative therapies through clinical development and guide cross-functional teams on compliance...
- 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
$177k - $278.08k
...and delivers transformative therapies to patients. By focusing R&D... ...develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products as GRA... .... to ensure alignment with global regulatory requirements and...Minimum wageLocal areaRemote workWorldwide$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 wageLocal areaRemote workWorldwide- Repertoire Immune Medicines is seeking an experienced Director of Regulatory Affairs to lead global regulatory strategy for Phase 1/2 oncology programs, based in... ...Development, CMC, and Quality to advance innovative therapies for patients. #J-18808-Ljbffr Repertoire Immune...Work at office3 days per week
$268.2k - $402.2k
...Vertex Pharmaceuticals seeks an experienced regulatory leader to develop and implement global regulatory strategies for Type 1 Diabetes programs. This executive role manages a team of regulatory professionals across multiple development stages and represents regulatory...$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$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- ...Vertex Pharmaceuticals LLC is seeking a Director of Regulatory Affairs CMC in Boston. The role leads a Regulatory CMC team, shaping global strategies for small molecule programs and coordinating Health Authority interactions across development and commercialization....
$150k - $165k
...development of groundbreaking therapies. Our mission is to be the... ...Performance Qualification (PPQ), regulatory readiness, and commercial... ...client relationships and account strategy, acting as a trusted advisor... ...manufacturing and its use in cell and gene therapy, gene editing, mRNA,...Full timeRemote workWork from homeFlexible hoursNight shift- ...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
- 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
- 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...
$200k - $230k
...new medicines, and cell and gene therapies. At Cytiva you will be able... ...makes everything possible. The Director, Strategic Growth &... ...Programs by connecting portfolio strategy, commercialization, and business... ....Serve as the primary global connection point across Fast...Full timeRemote workWork from homeFlexible hoursNight shift$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$186.23k - $279.35k
...Provide strategic and operational regulatory leadership to the development... ...of current local and global Regulatory trends to identifyfuture... ...regulatory requirements and strategies. Influence Regulatory... ...product developments regional therapy area· Represents AZRA on relevant...Full timeTemporary workWork at officeLocal areaWorldwideFlexible hours3 days per week$271.2k - $406.8k
...discover and develop therapies that take aim at... ...as tumor suppressor gene loss and their contribution... ...Executive Director, Commercial Strategy & Execution will lead... ...Marketing / Sales, Regulatory Affairs, Finance, and... ...to maximize value of global partnershipsOversee...Work experience placement$120k - $135k
...our people are impact-obsessed. As a global agency, we provide a full suite of services... ...Chemistry is looking for an Associate Director, Medical Strategy tojoin our growing team!Our Associate... ...and business needs.What you’ll do:Therapy area and scientific expertise: Guide teams...Work at officeLocal areaRemote work2 days per week$154.4k - $242.55k
...innovation and delivers transformative therapies to patients. By focusing R&D efforts... ...to shine? Join us as an Associate Director, Global Regulatory Project Management and Strategic Planning... ...in accordance with regulatory strategy for complex programs. Partner with the...Minimum wageFull timeLocal areaRemote workWorldwide- Ipsen is seeking a Global Marketing Director for Iqirvo to lead the development and execution of the global brand strategy, translating insights into an integrated lifecycle plan. The role partners with Medical Affairs, Market Access, HEOR, Corporate Affairs, Finance and...
$149k - $166k
...and delivering the next generation of gene editing therapies to patients. The Company is leveraging... ...clearly defined clinical development and regulatory path, and each expected to provide the... ...teams to ensure submissions to global health authorities (including the FDA...Full timeTemporary work$212k - $333.19k
...Job Description Join Takeda as the Global Market Access Strategy, Franchise Head out of our Cambridge, MA office. Where you will lead Global... ..., clinical development plans, integrated evidence plans, regulatory pathways and launch plans. Drive high-quality global...Minimum wageFull timeWork at officeLocal areaRemote work- Takeda in Boston, MA seeks a Director of Regulatory Strategy to define and lead global regulatory strategies for complex programs, collaborating cross-functionally to ensure compliance and timely submissions. The role leads GRTs, coordinates health authority interactions...
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