Global Regulatory Lead, Gene Therapy Programs
Arbor
Arbor Biotechnologies in Cambridge, MA is seeking a Director of Regulatory Affairs to lead regulatory strategy and execution across our preclinical and early clinical programs. Reporting to the Chief Medical Officer, you will serve as the Global Regulatory Lead on program teams and as the primary regulatory contact with the FDA and other health authorities. You will translate strategy into regulatory submissions, briefing materials, and agency interactions, collaborating with internal experts, #J-18808-Ljbffr Arbor
- ...Therapeutics, Inc. is seeking an Associate Director, Regulatory Affairs CMC to lead regulatory CMC efforts for a portfolio of gene-based medicines. You will collaborate with... ..., prepare high-quality submissions, and guide global teams through INDs, CTAs, #J-18808-Ljbffr...RegulatoryContract workWorldwide
- ...Cambridge, MA, seeks a visionary Program Leader to own the asset's... ...late-stage development through regulatory approval, launch, and lifecycle management. You will lead a cross-functional team across... ...FDA/EMA and guiding the asset to global commercialization to advance patients...Regulatory
$212k - $333.19k
...shine? Join us as a Senior Director, Global Program Lead- Neuroscience in our Cambridge, MA office... ...to simultaneously driving regulatory approval as well as launch and global... ...molecules or novel modalities such as Cell Therapy or Gene Therapy, large scale programs through...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote work- Lilly is seeking an experienced Regulatory CMC leader to develop and implement global CMC strategies for gene therapy programs. You will lead the preparation of CMC sections for IND/CTA, BLA/MAA submissions and serve as the primary liaison with major health authorities....Regulatory
$177k - $278.08k
...innovation and delivers transformative therapies to patients. By focusing R&D efforts... ...worldwide.Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the... ...submissions for high-impact oncology programs.How you will contribute:Oversee as well...RegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide$170k - $220k
A genetic medicine company in Boston is seeking an Associate Director of Regulatory CMC to lead regulatory strategy and bridge development with regulatory roles. This hybrid position requires strong regulatory affairs experience in biotechnology, excellent communication...Regulatory$232.5k - $335.83k
Job Title: Global Brand Lead, Transplant (Solid Organ Transplant)Location:... ...established anti-thymocyte globulin therapy, alongside a promising... ...Corporate Affairs, Digital, Regulatory, and regional commercial... ...healthcare, prevention and wellness programs and at least 14 weeks’...RegulatoryFull timeLocal area$190k - $240k
Orchard Therapeutics - U.S. is seeking a Regulatory Science expert to lead US regulatory strategy for gene therapy. The role involves collaboration with global teams to expedite FDA submissions while ensuring compliance across clinical development. Candidates should have...Regulatory$154.4k - $242.55k
....Job DescriptionThe Plasma-Derived Therapies (PDT) R&D Organization is dedicated... ...Sciences and Precision MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived... ...vision for early development programs and gains alignment from internal stakeholders...RegulatoryMinimum wageTemporary workLocal area$177k - $278.08k
...delivers transformative therapies to patients. By... ...the GRA CMC Franchise Lead for TAK-079 Independently develops the regulatory CMC strategy and leads... ...preparing the CMC aspects of global registrational submissions... ...risks through assigned programs / products development...RegulatoryMinimum wageFull timeTemporary workLocal areaWorldwide- ...seeking to recruit an experienced Global Asset Lead (GAL) to take end‐to‐end... ...of a priority oncology program. In this pivotal role, you will... ...integrating the efforts of Clinical, Regulatory, CMC, Medical Affairs, and... ..., earlier lines of therapy, and novel combination regimens...RegulatoryShift work
$208.2k - $327.14k
Global Therapeutic Research Lead - Immunology Job Description At Takeda, we are a forward... ...delivers transformative therapies to patients. By focusing... ...at least 3 discovery programs to clinic, The Global Therapeutic... ...industry, including regulatory requirements and...RegulatoryFull timeTemporary workFor contractorsLocal areaRemote workWorldwide- Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU) Responsibilities: Provide regulatory expertise and strategic guidance... ...labels. Prepare labeling vision for early programs; align stakeholders. Lead global labeling...Regulatory
$211.5k - $258.5k
...developing and delivering category‑leading precision therapies to transform the lives of people... ...fully. Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for... ...company's early‑stage and pipeline programs in the immunology and inflammation...RegulatoryLocal areaFlexible hours2 days per week- ...CRISPR Therapeutics, based in Boston, is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative gene therapies. This leadership role requires extensive experience in CMC regulatory requirements for biologics and gene therapies...RegulatoryRemote workFlexible hours
$206k - $257.5k
...robust portfolio of programs across muscle, central... ...launched our fourth therapy and the first ever gene therapy to treat... ...the Vice President, Global Medical Affairs Strategy... ...Field, the MSL Team Lead is responsible for... ...complying with industry and regulatory compliance...RegulatoryFull time- Vertex Pharmaceuticals Incorporated is seeking an Executive Director, Regulatory Strategy to lead global regulatory strategies for Type 1 Diabetes programs. You will supervise a team of regulatory professionals and shape cohesive regulatory plans across development and...Regulatory
- ...medical leader to provide strategic direction across global immunology programs. You will guide clinical development planning,... ...scientific rigor and patient centricity. The role includes leading cross-functional teams, regulatory interactions, and governance communications. You...Regulatory
- Scorpion Therapeutics seeks an Associate Director, Global Submission Management to orchestrate global regulatory submissions across development and lifecycle programs. This role focuses on Pulmonary or Cell & Gene Therapy areas and partners with Strategy, CMC, Labeling,...Regulatory
- ...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 Regulatory...Regulatory
$190k - $240k
...a Kyowa Kirin company, is a global gene therapy leader focused on transforming... ...gene therapy clinical programs. They demonstrate leadership... ...serve as a team mentor, and lead national level initiatives.... ...with internal and external regulatory and legal guidelines.· Maintain...RegulatoryFull timeLocal areaRemote work- ...Therapeutics LP in Cambridge, MA is seeking a Program Toxicologist to provide scientific and... .... The role collaborates with program leads and subject-matter experts to advance... ...as needed; ensure risk assessments and regulatory submissions support INDs. #J-18808-Ljbffr...Regulatory
$212k - $318k
...Cystic Fibrosis (CF), Casgevy, a gene therapy for sickle cell disease and... ...than a dozen ongoing research programs focused on the underlying mechanisms... ...serve as a T1D Market Access Lead within our Cell and Gene Therapy (CGT) portfolio in the Global Value and Access Strategy (...Full timeSummer workRemote workFlexible hours2 days per week$229.56k - $344.35k
...a visionary and strategic Program Leader to serve as the single... ...development through regulatory approval, global launch, and lifecycle management... ...the Program Leader, you will lead the Program Team, aligning... ...to deliver transformative therapies to patients with rare diseases...RegulatoryTemporary workWork at officeFlexible hours3 days per week- A global pharmaceutical company is seeking an Associate Director for Global Regulatory Affairs. This role involves acting as a Subject Matter Expert and managing all assigned programs while ensuring compliance with advertising and promotion regulations. Candidates should...RegulatoryRemote work
$154.4k - $242.55k
...and empower you to shine? Join us as Global Biomarker Lead, Inflammation, GI2 TAU based in Cambridge... ...and inflammation portfolio programs. This highly visible, strategic, and matrixed... ...protocols and documents submitted to Regulatory Agencies.• Establish and maintain scientific...RegulatoryMinimum wageTemporary workLocal area$136.4k - $253.2k
...Data Science is recognized as a leading hub for top industry talent,... ...agile workforce to deliver regulatory commitments across the portfolio... ..., and align statistical programming practices across both early-... ...support internal audits and global health authority inspectionsYou...RegulatoryFull timeLocal area$154.4k - $242.55k
...knowledge.Job DescriptionAbout the Role:The Global Brand Lead, ITP (Associate Director) is... ...partners closely with Medical, Legal, and Regulatory teams to ensure materials are compliant... ...insurance, a tuition reimbursement program, paid volunteer time off, company holidays...RegulatoryMinimum wageTemporary workLocal areaRemote work- ...status quo for the better. Chiesi Global Rare DiseasesChiesi Global... ...the Americas, this role will lead the development and... ...Review Committee (Legal/Medical/Regulatory) and experience with VeevaVault... ...discretionary payment or compensation program) at any time, including for...RegulatoryHourly payWork at officeLocal areaRemote workRelocation packageFlexible hours
- The Global Study Lead (Sr. Manager, Clinical Operations) is responsible for leading the operational... ...execution in support of development program goals.This is a hybrid role preferably... ..., Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which...RegulatoryFull timeTemporary workLocal areaRemote workFlexible hours
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