Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

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

Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the US Regulatory Strategy Lead for Biologics & Cell Therapies in Boston, MA vacancy
  • $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... 
    Regulatory
    Hourly pay
    Full time
    Temporary work
    Start working today
    Work at office
    Flexible hours
    3 days per week

    AstraZeneca

    Boston, MA
    10 hours ago
  • $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... 
    Regulatory
    Hourly pay
    Full time
    Temporary work
    Work at office
    Local area
    Flexible hours
    3 days per week

    AstraZeneca

    Boston, MA
    10 hours ago
  •  ...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... 
    Regulatory
    Flexible hours

    Confidential

    Boston, MA
    4 days ago
  • $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

    Bayer CropScience Limited

    Cambridge, MA
    2 days ago
  •  ...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

    Voisin Consulting SARL

    Boston, MA
    1 day ago
  • $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... 
    Regulatory
    Full time
    Contract work
    Temporary work
    Work experience placement
    Flexible hours

    Servier Pharmaceuticals

    Boston, MA
    1 day ago
  • $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... 
    Regulatory
    Remote job
    Full time
    Contract work
    Temporary work
    Work at office
    Relocation
    Relocation package
    Monday to Friday
    Shift work
    Night shift
    Weekend work
    Day shift
    Afternoon shift
    Boston, MA
    9 days ago
  •  ...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

    Discover International

    Boston, MA
    1 day ago
  •  ...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

    Dormont Manufacturing Co

    Cambridge, MA
    3 days ago
  • 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

    Takeda

    Boston, MA
    1 day ago
  • $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

    Vertex Pharmaceuticals Inc (US)

    Boston, MA
    2 days ago
  • $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... 
    Regulatory
    Minimum wage
    Full time
    Temporary work
    Local area
    Worldwide

    JobRx, Inc.

    Boston, MA
    17 hours ago
  • $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... 
    Regulatory
    Minimum wage
    Full time
    Temporary work
    Local area
    Worldwide

    Takeda

    Boston, MA
    4 days ago
  • $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... 
    Regulatory
    Remote work
    2 days per week

    Vertex US Distribution

    Boston, MA
    3 days ago
  • $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... 
    Regulatory
    Minimum wage
    Full time
    Temporary work
    Local area

    Takeda Pharmaceuticals International GmbH

    Cambridge, MA
    2 days ago
  • $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 work
    Remote work
    Worldwide
    Flexible hours
    2 days per week

    Role, Inc.

    Boston, MA
    17 hours ago
  •  ...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

    RAPTOR MEDICINES INC

    Boston, MA
    2 days ago
  • $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... 
    Regulatory
    Minimum wage
    Temporary work
    Local area
    Remote work

    Takeda Pharmaceutical Company Ltd

    Cambridge, MA
    2 days ago
  • $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... 
    Regulatory
    Minimum wage
    Temporary work
    Local area
    Remote work

    BioSpace

    Boston, MA
    1 day ago
  • 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 work
    Remote work
    Flexible hours
    2 days per week

    Vertex Pharmaceuticals

    Boston, MA
    2 days ago
  •  ...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... 

    Vertex Pharmaceuticals

    Boston, MA
    17 hours ago
  • $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 area
    Worldwide
    Relocation

    Merck & Co.

    Cambridge, MA
    4 days ago
  • 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... 
    Regulatory
    Hourly pay
    Full time
    Temporary work
    Work at office

    AstraZeneca

    Waltham, MA
    1 day ago
  •  ...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

    Mass Digital Health

    Cambridge, MA
    1 day ago
  •  ...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... 
    Regulatory
    Work at office
    Local area
    Shift work

    Dormont Manufacturing Co

    Cambridge, MA
    1 day ago
  • $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... 
    Regulatory
    Local area

    Dormont Manufacturing Co

    Cambridge, MA
    4 days ago
  •  ...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... 
    Regulatory
    Local area

    GlaxoSmithKline

    Cambridge, MA
    3 days ago
  • 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... 
    Regulatory
    Work at office
    3 days per week

    Bicara Therapeutics

    Boston, MA
    4 days ago
  • 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

    Initial Therapeutics, Inc.

    Boston, MA
    17 hours ago
  • $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... 
    Regulatory
    Summer work
    Remote work
    Flexible hours
    2 days per week

    Vertex Pharmaceuticals

    Boston, MA
    3 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to US Regulatory Strategy Lead for Biologics & Cell Therapies. Be the first to apply!