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
$218.06k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations:... ...for patients? This role leads high-impact programs across... ...experience of overall drug/biologic development processes and... .... In-person working gives us the platform we need to connect...RegulatoryHourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$186.23k - $279.35k
Job Title: Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg... ...global teams, you will lead strategy across key milestones... ...of overall drug/biologic development processes and... .... In-person working gives us the platform we need to connect...RegulatoryHourly payFull timeTemporary workWork at officeLocal areaFlexible hours3 days per week- ...Executive Director, Regulatory Affairs Strategy, Cell & Gene Therapy About the Company Respected biopharmaceutical... ...candidate will be responsible for leading high-impact programs, guiding them... ...global regulatory science, drug/biologic development processes, and...RegulatoryFlexible hours
$299.7k
...innovative healthcare company is seeking a GME Strategy Lead in Cambridge, MA. The role involves... ...medical strategy for a pioneering cell therapy targeting Parkinson’s Disease. Ideal candidates... ...42, including additional benefits. Join us in a mission to drive health...Suggested- ...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
$180k - $210k
...City: Boston Country/Region: US Type of Contract: Full-time Employment... ...Associate Director, Corporate Strategy About Servier Servier in the... ...Associate Director will both lead independent workstreams end-to... ...markets, drug development, regulatory processes, and commercial and...RegulatoryFull timeContract workTemporary workWork experience placementFlexible hours$110k - $125k
...Supervisor) – Cell and Gene – Cell... ...locations within the US. Please note... ...life-changing therapies. With clinical... ...business is a leading global contract... ...standards and or regulatory expectations.... ...align testing strategies and support program... ..., Immunology, Biology, Molecular...RegulatoryRemote jobFull timeContract workTemporary workWork at officeRelocationRelocation packageMonday to FridayShift workNight shiftWeekend workDay shiftAfternoon shift- ...Manager/Associate Director for Global Regulatory Affairs CMC in Boston, MA. This... ...involves supporting regulatory strategy and execution for innovative biologic therapies. The ideal candidate will have... ...regulatory frameworks. You will lead global regulatory submissions...Regulatory
- ...looking for a Head of Regeneron Cell Medicines to set the vision and strategy for its cell medicine... ...Cambridge, MA. This role involves leading multidisciplinary teams and overseeing... ...development of transformative therapies while ensuring regulatory compliance. Ideal candidates...Regulatory
- Takeda is seeking a Manager Regulatory Lead in Boston, MA. In this role, you will orchestrate regulatory strategy and life cycle activities for plasma-derived therapies. Your expertise will guide a team ensuring compliance with relevant regulations while developing effective...Regulatory
$196.8k - $295.2k
Vertex Pharmaceuticals Inc (US) is seeking a Regulatory Strategy Director in Boston, MA. In this role, you will lead the development and implementation of global regulatory strategies... ...candidate will have a Bachelor's degree in Biology or Chemistry and typically requires 10...Regulatory$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 wageFull timeTemporary workLocal areaWorldwide$208.2k - $327.14k
...delivers transformative therapies to patients. By... ...conjugates (ADCs), complex biologics and small molecules. Our... ...Director, Global Regulatory Lead - Oncology, where you... ...ideas into actionable strategies. You will set global regulatory... .... Accountable for US FDA submissions and...RegulatoryMinimum wageFull timeTemporary workLocal areaWorldwide$196k - $294k
...collaborative leader to join the US Pain Business Unit to support... ..., Key Thought Leader (KTL) Strategy & Professional Organizations... ...responsible for building and leading a comprehensive KTL... ...activities comply with legal, regulatory, and ethical standards; manage...RegulatoryRemote work2 days per week$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.... ...simultaneously. Knowledge of regulatory requirements and compliance...RegulatoryMinimum wageFull timeTemporary workLocal area$240k - $360k
...Fibrosis (CF), Casgevy, a gene therapy for sickle cell disease and beta-thalassemia... ...of the kidney that can lead to end-stage-renal disease.... ...Director of Global Value & Access Strategy (GVAS) for povetacicept,... ...Deep working knowledge of both US and ex-US healthcare systems...Summer workRemote workWorldwideFlexible hours2 days per week- ...Scientist/Senior Scientist, Biology Lead - Kidney Experience About the... ...hypotheses, delivery strategies, and biomarker plans Contribute... ...chemistry, delivery, translational, regulatory, and external teams Help... ...Nephrology, Renal Biology, Cell Biology, Molecular Biology,...Regulatory
$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$212k - $333.19k
...group of experienced biologic drug hunters with the... ...and the resources of a leading pharmaceutical company... ...IND filing Discovery strategy and implementation: Establish... ..., hybridoma, single B cell), lead optimization,... ...acumen including regulatory (BLA/MAA pathway) and...RegulatoryMinimum wageTemporary workLocal areaRemote work- Strategy and Operations Associate Director, Cell & Genetic Therapy ResearchSkip to main content#Strategy and Operations... ...to audience needs.* Lead development of... ...Experience:*** PhD in biology or related discipline,... ...About Vertex## **Help Us Achieve Our Mission**##...Summer workRemote workFlexible hours2 days per week
- ...seeking a Principal Scientist in Stem Cell Research. This hands-on role... ...setting scientific standards, and leading the development of cellular... ...doctoral experience in stem cell biology, demonstrating expertise in experimental strategy and team leadership. A competitive...
$299.7k
...perspectives of those around us, expanding our thinking, growing... ...area of innovation has been Cell Therapy & Gene Therapy (CGT), where... ...advances via the acquisition of two leading companies in this space,... ...deliver medical & evidence strategy and leadership for commercial...Local areaWorldwideRelocation- Within the AstraZeneca Cell Therapy Unit (CTU), our... ...registrational investment strategies. This individual will... ...Typical Accountabilities: · Leads one or more Cell... ...development, coupled with regulatory knowledge · Strong... ...tools) · Experience in US and/or Global commercialization...RegulatoryHourly payFull timeTemporary workWork at office
- ...future of medicine. This role involves leading the development and maintenance of global labeling strategies for products, ensuring regulatory compliance while working with cross-functional... ...skills and a proactive attitude. Join us to drive breakthroughs in drug discovery...Regulatory
- ...delivers life-changing therapies for people with... ...global leader in the biology of the transforming growth... ...(TGFβ) superfamily of cell proteins and named for... ...Director or Senior Director, Regulatory Strategy, reporting to the SVP,... ...candidate will lead interactions with the...RegulatoryWork at officeLocal areaShift work
$300k
Head of Regeneron Cell Medicines... ...sets the vision, strategy, and execution... ...transformative cell‑based therapies. Based in... ...Oversight Lead matrixed teams... ...Development, Clinical, Regulatory, Quality, CMC,... .../PhD) in cell biology, immunology,... ...in the US, please visit...RegulatoryLocal area- ...doing the right thing. Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for mature vaccine projects in... ...S. for FDA communications. CMC experience for biologics, including regulatory requirements and technical...RegulatoryLocal area
- Bicara Therapeutics is seeking a Senior Director of Regulatory Affairs in Boston. This role will lead US regulatory strategy for the biologics pipeline, overseeing regulatory submissions and health authority interactions. The ideal candidate will have 10-12 years of experience...RegulatoryWork at office3 days per week
- Initial Therapeutics, Inc. is seeking a Manager Regulatory Lead in Boston, MA. This role involves developing regulatory strategies for plasma-derived therapies, coordinating team meetings, and liaising with the US FDA. The ideal candidate should have at least 4 years of...Regulatory
$176k - $264k
## Director, Biologics Development Operational... ..., quality and regulatory objectives.**... ...expectations* Lead the... ...operational and quality strategies aligned with business... ...**Help Us Achieve Our Mission... ..., sickle cell disease and transfusion... ...therapies across a range...RegulatorySummer workRemote workFlexible hours2 days per week
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