US Regulatory Strategy Lead, Gene Therapy
$190k - $240kOrchard Therapeutics - U.S.
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 extensive experience in US regulatory affairs and a PharmD or PhD. Salary ranges from $190,000 to $240,000 with a comprehensive benefits package. #J-18808-Ljbffr Orchard Therapeutics - U.S.
- Voisin Consulting SARL is seeking a Senior Director of US Regulatory Strategy in Boston to lead regulatory guidance for biotech and pharmaceutical... ...BLA submissions, with a focus on complex biologics and therapies, emphasizing strong client relationships and business...Regulatory
- ...Boston, is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative gene therapies. This leadership role requires extensive experience... ...a collaborative work environment with flexible remote options. #J-18808-Ljbffr Jobleads-USRegulatoryRemote workFlexible hours
$190k - $240k
...Remote, Eastern Territory US Reporting to: Senior... ...Kirin company, is a global gene therapy leader focused on transforming... ...the Sr MSL will develop strategy, serve as a team mentor, and lead national level... ...with internal and external regulatory and legal guidelines.· Maintain...RegulatoryFull timeLocal areaRemote work- AbbVie in Cambridge, MA seeks a Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Therapeutic Neurotoxins to develop and implement regulatory strategies for on-market and development-stage products. You will coordinate data gathering for filings, responses...Regulatory
$206k - $257.5k
...In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We’... ...President, Global Medical Affairs Strategy and Field, the MSL Team Lead is responsible for the... ...of complying with industry and regulatory compliance guidelines; ability...RegulatoryFull time- ...Pharmaceuticals is seeking an Associate Director of Regulatory Affairs Strategy in Cambridge, Massachusetts. The role involves leading regulatory strategy for CNS programs and... ...timely submission of regulatory documents to the US. Applicants should have a Bachelor's degree...Regulatory
- ...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... ...and partners to devise innovative regulatory strategies while coordinating with contract...RegulatoryContract workWorldwide
$178.5k - $257.83k
Job Title: Lead, US Hematology Pipeline CommercializationLocation... ...delivery of transformative therapies for patients affected by debilitating... ...shaping the US commercial strategy, market development approach... ...among clinical, regulatory, medical, access, and commercial...RegulatoryFull time- Eli Lilly and Company seeks a Director/Senior Director, Regulatory CMC to lead regulatory CMC strategies for our gene therapy portfolio, guiding from development through commercialization. You will author and review high‑quality CMC submissions and serve as the main liaison...Regulatory
- ...portfolio. For more information about AbbVie, please visit us at Follow @abbvie on LinkedIn, Facebook, Instagram, X... ..., X and YouTube. Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Therapeutic Neurotoxins is responsible for the...RegulatoryLocal area
$268.2k - $402.2k
## Executive Director, Regulatory Strategy, Cell & Gene TherapyApplylocations: Boston,... ...Duties and Responsibilities:*** Leads the development of... ...com### About Vertex## **Help Us Achieve Our Mission**## *Vertex... ...of investigational therapies across a range of modalities...RegulatorySummer workLocal areaRemote workFlexible hours2 days per week$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- Vertex Pharmaceuticals is seeking an Executive Director of Regulatory Strategy for its Cell & Gene Therapy portfolio focused on Type 1 Diabetes. This global leadership role manages a team of regulatory professionals and drives innovative strategies for development and commercialization...Regulatory
- Galderma seeks an experienced regulatory affairs leader to drive US policy and advocacy, shaping the regulatory environment for our dermatology portfolio. You will influence FDA interactions, lead strategy, and coordinate with global teams to align US plans with worldwide...RegulatoryWorldwide
- Biogen, Inc. in Cambridge, MA, seeks a US Lifecycle Management Lead with senior IC responsibilities to govern end-to-end launches and lifecycle events, ensuring supply, quality, regulatory alignment and commercial readiness. You will lead early launch activities, work with...Regulatory
$185k - $210k
...developing and delivering innovative therapies to improve the lives of people who live... ...and culture at Sobi North America get us excited to come to work every day, but... ...treatments Job Description The US Regulatory Strategy lead is responsible for all aspects of the...RegulatoryOdd jobFull timeTemporary workWork experience placement- ...Consulting Life Sciences (VCLS) is seeking a Senior Director of US Regulatory Strategy to guide biotechnology and pharmaceutical clients through... ...stage development of biologics, combination products, and gene therapies. The ideal candidate will bring significant experience in...Regulatory
- ...Director or Executive Director of US Regulatory Strategy to join our growing... ...developing innovative and complex therapies. The successful candidate... ...Experience supporting cell and gene therapies is highly... ...Regulatory Strategy Leadership Lead development and execution of...Regulatory
$212k - $318k
...Cystic Fibrosis (CF), Casgevy, a gene therapy for sickle cell disease and... ...serve as a T1D Market Access Lead within our Cell and Gene Therapy... ...the Global Value and Access Strategy (GVAS) team.The individual will... ...International P&R, Corporate Affairs, US Managed Markets, Countries,...Full timeSummer workRemote workFlexible hours2 days per week$211.5k - $258.5k
...company focused on developing and delivering category‑leading precision therapies to transform the lives of people living with autoimmune... ...diseases can live life fully. Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing...RegulatoryLocal areaFlexible hours2 days per week$177k - $278.08k
...and delivers transformative therapies to patients. By focusing R&D... ...Takeda as a Director, Global Regulatory Lead Oncology where you will be part... ...you will set global regulatory strategy and lead major submissions... ...responsibility.Accountable for all US FDA submissions and approvals...RegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide$202.4k - $265.7k
...patientsWe are looking for a RWE Strategy Lead Developed Brands, Immunology... ...and patient impact of UCB’s therapies. You will identify critical... ...data strategies that inform regulatory, market access, reimbursement... ...love to hear from you! About us UCB is a global biopharmaceutical...RegulatoryPermanent employmentContract workWork at officeLocal area$154.4k - $242.55k
...role: The Brand Insights and Analytics Lead, US Oncology is an Associate Director-level... ...the development and execution of brand strategies that drive brand awareness, market performance... ...projects simultaneouslyKnowledge of regulatory requirements and compliance guidelines...RegulatoryMinimum wageTemporary workLocal areaRemote work- ...the planet. This is what drives us as we research, develop, and market... ...to the Head of Access Marketing, Strategy, & US HEOR for the Americas, this role will lead the development and... ...Review Committee (Legal/Medical/Regulatory) and experience with VeevaVault or...RegulatoryHourly payWork at officeLocal areaRemote workRelocation packageFlexible hours
$122.25k - $176.58k
Job title: Lead, US Public Affairs & Patient Advocacy Rare DiseasesLocation: Cambridge, MAAbout... ...integrated into Sanofi's rare disease strategy.Reports To: Head, US Public Affairs and... ...teams including Medical Affairs, Regulatory Affairs, Market Access, Health Economics...RegulatoryFull timeRemote work$148.5k - $214.5k
Job title: US Neurology and Immunology Asset/Indication Lead Location: Cambridge, MAAbout the Job: Sanofi's specialty... ..., value-based contracting strategies, etc.Set HEOR evidence generation... ...thorough understanding of the legal and regulatory environment of the pharmaceutical...RegulatoryFull timeContract work$71.25k - $161.7k
...pharmaceutical industry. Responsibilities include reviewing analytical data, managing laboratory projects, and ensuring adherence to regulatory requirements. The expected compensation ranges from $71,250 to $161,700, and the role requires on-site presence in our Boston lab...Regulatory$178.5k - $257.83k
Job title: US HEVA Neurology Asset/Indication LeadLocation... ...of innovative therapies — addressing a range of... ...access. As HEOR experts, we lead the generation and... ...accountable for leading US HEOR strategy and execution for the... ...of the legal and regulatory environment of the...RegulatoryFull timeWork at office3 days per week$136.86k - $195.51k
...provide transformative therapies in disease areas that include... ....Purpose & Scope The Lead, Upstream Marketing... ...professional marketing strategies focused on educating and... ...Market Access, Legal, Regulatory, and Compliance to deliver... ...from anywhere in the US is available.This...RegulatoryWork at officeRemote workWork from homeWorldwide$232.5k - $335.83k
Job Title: Global Brand Lead, Transplant (Solid... ...countries including the US, China, and the EU. Our... ...anti-thymocyte globulin therapy, alongside a promising... ...SOT therapeutic area, strategy, P&L, and market, in preparation... ...Affairs, Digital, Regulatory, and regional commercial...RegulatoryFull timeLocal area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to US Regulatory Strategy Lead, Gene Therapy. Be the first to apply!

