US Regulatory Strategy Lead for Biologics & Cell Therapies
Voisin Consulting SARL
Voisin Consulting SARL is seeking a Senior Director of US Regulatory Strategy in Boston to lead regulatory guidance for biotech and pharmaceutical clients. This critical role involves strategic oversight of BLA submissions, with a focus on complex biologics and therapies, emphasizing strong client relationships and business development. The ideal candidate will have extensive experience in FDA regulatory strategy, particularly for biologics, and excellent leadership and consulting skills. This position offers the opportunity to mentor teams and contribute to the growth of a dynamic consultancy. #J-18808-Ljbffr Voisin Consulting SARL
- ...Sciences (VCLS) is seeking a Senior Director of US Regulatory Strategy to guide biotechnology and pharmaceutical clients... ..., particularly in the late-stage development of biologics, combination products, and gene therapies. The ideal candidate will bring significant...Regulatory
$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$178.5k - $257.83k
Job Title: Lead, US Hematology Pipeline CommercializationLocation... ...of transformative therapies for patients affected... ...the US commercial strategy, market development... ...Anemia (wAIHA) and sickle cell disease. This role... ...relationship among clinical, regulatory, medical, access, and...RegulatoryFull time- 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
- ...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
- ...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
- ...Executive Director of US Regulatory Strategy to join our growing... ...innovative and complex therapies. The successful... ...commercialization of complex biologics, such as combination... ...supporting cell and gene therapies is... ...Strategy Leadership Lead development and execution...Regulatory
$268.2k - $402.2k
...DescriptionGeneral Summary:The Executive Director, Regulatory Strategy will serve as a seasoned regulatory... .... Key Duties and Responsibilities:Leads the development of regulatory strategy... ...and Experience:Bachelor's degree in Biology, Chemistry, or other related disciplineTypically...RegulatoryFull timeSummer workLocal areaRemote workFlexible hours2 days per week$211.5k - $258.5k
...developing and delivering category‑leading precision therapies to transform the lives of people living... ...fully. Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is... ...regulatory strategy development for biologics and/or small molecule therapeutics,...RegulatoryLocal areaFlexible hours2 days per week- ...seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative gene therapies. This leadership role... ...regulatory requirements for biologics and gene therapies. The ideal... ...flexible remote options. #J-18808-Ljbffr Jobleads-USRegulatoryRemote workFlexible hours
$206k - $257.5k
...diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to... ...President, Global Medical Affairs Strategy and Field, the MSL Team Lead is responsible for the development... ...of complying with industry and regulatory compliance guidelines; ability to apply...RegulatoryFull time$177k - $278.08k
...delivers transformative therapies to patients. By... ...including ADCs, complex biologics and small molecules. Our... ...as a Director, Global Regulatory Lead Oncology where you will... ...set global regulatory strategy and lead major submissions... ....Accountable for all US FDA submissions and...RegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide$154.4k - $242.55k
...Brand Insights and Analytics Lead, US Oncology is an Associate... ...development and execution of brand strategies that drive brand awareness,... ...intelligence in specialty biologics healthcare environment.... ...simultaneouslyKnowledge of regulatory requirements and compliance...RegulatoryMinimum wageTemporary workLocal areaRemote work$178.5k - $257.83k
Job title: US HEVA Neurology Asset/Indication... ...of innovative therapies — addressing a... ...HEOR experts, we lead the generation and... ...for leading US HEOR strategy and execution for... ...of the legal and regulatory environment of the... ...action (including biologics and targeted therapies...RegulatoryFull timeWork at office3 days per week$232.5k - $335.83k
...Title: Global Brand Lead, Transplant (Solid... ...Hematopoietic Stem Cell Transplantation (HSCT... ...including the US, China, and the EU.... ...thymocyte globulin therapy, alongside a promising... ...therapeutic area, strategy, P&L, and market, in... ...Affairs, Digital, Regulatory, and regional commercial...RegulatoryFull timeLocal area$195k - $330k
...building an industry-leading pipeline of oral... ...highly effective therapies for patients with... ...visit or follow us on X (formerly Twitter... ...and biomarker strategies to support early and... ...platforms (e.g., cell-based assays, molecular... ...manuscripts and regulatory documents (e.g....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
- 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
$154.4k - $242.55k
...DescriptionThe Plasma-Derived Therapies (PDT) R&D Organization is... ...MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma... ...lifecycle management of the CCDS, US, and EU labels.Formulates... ...-derived therapies and biologics preferred.Bachelor’s or...RegulatoryMinimum wageTemporary workLocal area$238k - $374k
...group of experienced biologic drug hunters with the... ...and the resources of a leading pharmaceutical company... ...and evolve the program strategy for antibody, bispecific... ..., hybridoma, single B cell), lead optimization,... ...business acumen including regulatory (BLA/MAA pathway) and...RegulatoryMinimum wageTemporary workLocal areaRemote work- ...disorders. These are therapies designed to work... ...the body's own biology and stop bleeds before... ...-to-end medical strategy for one or more Hemab... .... Partner with Regulatory, Clinical... ...asset narrative. Lead the publication and... ...your experience with us falls short of it,...RegulatoryShift work
$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$190k - $240k
...Eastern Territory US Reporting to: Senior... ..., is a global gene therapy leader focused on transforming... ...hematopoietic stem cells (HSCs). Orchard has... ...MSL will develop strategy, serve as a team mentor, and lead national level... ...and external regulatory and legal guidelines...RegulatoryFull timeLocal areaRemote work$241k - $332k
About This Role:As the Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products (ATMP), you will lead a dynamic team within the PO... ..., driving the regulatory strategy for biologics and ATMPs in Biogen... ..., and perspectives make us a stronger and more...RegulatoryFull timeTemporary workLocal area- ...Scientist/Senior Scientist, Biology Lead – Kidney Experience About... ...therapeutic hypotheses, delivery strategies, and biomarker plans ·... ..., delivery, translational, regulatory, and external teams ·... ...Nephrology, Renal Biology, Cell Biology, Molecular Biology,...Regulatory
- ...medicines for Cystic Fibrosis (CF), sickle cell disease, beta-thalassemia, and... ...an experienced Senior Director, US Market Access Strategy to lead market access initiatives for povetacicept... ...and commercial payers, policy, and regulatory environmentPharmacy and medical...RegulatoryFull timeContract workSummer workRemote workRelocationFlexible hours2 days per week3 days per week
$212k - $318k
...Fibrosis (CF), Casgevy, a gene therapy for sickle cell disease and beta-thalassemia... ...as a T1D Market Access Lead within our Cell and Gene Therapy... ...the Global Value and Access Strategy (GVAS) team.The individual... ...International P&R, Corporate Affairs, US Managed Markets, Countries,...Full timeSummer workRemote workFlexible hours2 days per week$183.77k - $275.65k
...Translational Medicine Lead, Associate... ...for novel targeted therapies and translate it into... ...guide indication strategy, dose and schedule... ...you connect disease biology with clinical... ...applicable quality, regulatory, ethical, safety,... ...person working gives us the platform we...RegulatoryHourly payTemporary workWork at officeFlexible hours3 days per week$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$267.91k - $401.87k
Within the AstraZeneca Cell Therapy Enterprise, our ambition is to realize... ...’s Therapeutic Area Units. Strategy and Commercial Executive Director... ...within Cell Therapy. You will lead global commercial and... ...medicines. In-person working gives us the platform we need to connect...Temporary workWork at officeFlexible hours3 days per week
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