Regulatory Strategy Exec Director, Biologics & Cell Therapies
Voisin Consulting Life Sciences (VCLS)
Voisin Consulting Life Sciences (VCLS) is seeking a Senior Director of US Regulatory Strategy to guide biotechnology and pharmaceutical clients through complex regulatory landscapes. This leadership role will focus on US FDA regulatory strategy, particularly in the late-stage development of biologics, combination products, and gene therapies. The ideal candidate will bring significant experience in industry, expertise in BLA submission, and the ability to mentor teams while fostering client relationships. Strong communication and leadership skills are essential, along with a degree in a life sciences discipline. #J-18808-Ljbffr Voisin Consulting Life Sciences (VCLS)
$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica, CAIntroduction... ...strategy.Long standing experience of overall drug/biologic development processes and strategies for high...RegulatoryHourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$276k - $414k
Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica,... ...strategy. Long-standing experience of overall drug/biologic development processes and strategies for high profile...RegulatoryHourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week$268.2k - $402.2k
Job DescriptionGeneral Summary:The Executive Director, Regulatory Strategy will serve as a seasoned regulatory leader with expert technical and tactical... ...these valuesEducation and Experience:Bachelor's degree in Biology, Chemistry, or other related disciplineTypically requires...RegulatoryFull timeSummer workLocal areaRemote workFlexible hours2 days per week$150k - $211k
...advances in targeted therapies for patient... ...SummaryReporting to the Director of Drug Substance (Biologics), MSAT, this role is... ...management, and global regulatory submissions of... ...lifecycle management strategies for assigned... ...fermentation & mammalian cell culture) and chromatography...RegulatoryTemporary workRemote workWorldwideFlexible hours$267.91k - $401.87k
Within the AstraZeneca Cell Therapy Enterprise, our ambition is to realize the full potential of cell therapy for people... ...with AstraZeneca’s Therapeutic Area Units. The Strategy and Commercial Executive Director, Cell Therapy Strategy and Commercial (CTSC), is a high...SuggestedFull timeTemporary workWork at officeFlexible hours3 days per week$200k - $300k
...delivers life-changing therapies for people with serious... ...a global leader in the biology of the transforming growth... ...beta (TGFβ) superfamily of cell proteins and named for... ...Summary of Position The Director or Senior Director, Regulatory Strategy, reporting to the SVP, Global...RegulatoryWork at officeLocal areaShift work- AstraZeneca is seeking a Strategy and Commercial Executive Director, Cell Therapy Strategy and Commercial (CTSC), to shape end-to-end strategy for a defined indication within the Cell Therapy Enterprise. You will lead global commercial and strategic initiatives, partner...
- AstraZeneca GmbH is seeking a Strategy and Commercial Executive Director for Cell Therapy Strategy and Commercial. You will shape end-to-end strategy across a defined indication, lead global commercial initiatives, and partner with Therapeutic Areas on clinical strategy...
- ...Cell Therapy Strategy & Commercial Executive Director About the Company Respected biopharmaceutical company Industry Pharmaceuticals Type Public Company Founded 1999 Employees 10,001+ Categories Health and Wellness Medical Pharmaceuticals...
- ...with the execution of validation protocols.May participate in regulatory inspections and/or the implementation of corrective actions arising... ...(HEPP).Basic laboratory skills, including working with mammalian cell cultureExperience working in an ISO 7 cleanroom environment.RegulatoryWork at officeWeekend workAfternoon shift
- Director/Associate Director, Cell Therapy CMC & Manufacturing We are seeking a highly experienced... ...will help lead CMC strategy, manage process development... ...transfer. Contribute to regulatory filings (CMC sections of... ...preferred) or MS in Cell Biology, Immunology, Bioengineering...Regulatory
- Research Scientist, Cell and Gene Therapy Analytical (Contract) This Research Scientist position... ...technical reports. Prepare and review regulatory filings and responses. Knowledge and... ...supporting late-stage or commercial biological products and cGMP manufacturing. Ability...RegulatoryContract work
- Director, Stem Cell & Regenerative Medicine We are seeking an... ...and manage research strategies to support discovery,... ...preclinical validation, and regulatory submissions. Provide... ...in stem cell biology, immunology, and regenerative... ..., cell therapy manufacturing, and regulatory...Regulatory
$212k - $318k
...Cystic Fibrosis (CF), Casgevy, a gene therapy for sickle cell disease and beta-thalassemia and Journavx... ...patients faster than ever before.The Director, T1D will serve as a T1D Market Access... ...in the Global Value and Access Strategy (GVAS) team.The individual will be responsible...Full timeSummer workRemote workFlexible hours2 days per week$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&T function, driving the regulatory strategy for biologics and ATMPs in Biogen’s portfolio. Your role encompasses global, regional...RegulatoryFull timeTemporary workLocal area- ...Summary:The Executive Director serves as a... ...defining and executing the Cell & Genetic Therapies (CGT) Quality vision... ...and organizational strategy. The role is accountable... ..., and global regulatory requirements to support... ...Gene therapy and/or Biologics.Broad and deep technical...RegulatoryFull timeSummer workFlexible hours
- ...optimization, and qualification of cell-based potency assays that evaluate the biological activity of cell therapy products. Design and execute... ..., specifications, and regulatory support documents.... ...Regulatory to advance analytical strategies throughout product development...RegulatoryContract work
- ...Strategic Operations Director serves as the end-to-end... ...value within Global Regulatory Affairs (GRA). Drives... ...cystic fibrosis, sickle cell disease and transfusion... ...of investigational therapies across a range of modalities... ...into causal human biology, including APOL1-mediated...RegulatorySummer workRemote workFlexible hours2 days per week
$227k - $283.79k
...of transformative therapies for patients with... ...Our core business strategy combines our experienced... ...present across B cell lineage, to... ...Summary:The Senior Director, Biomarker Development... ...Operations, Regulatory, Medical Affairs,... ...of-action, disease biology, predictive, prognostic...Regulatory- Vertex Pharmaceuticals seeks an Associate Director, Shift Quality Operations to lead real-time QA on aseptic cell therapy manufacturing on-site in Boston. You will oversee... ...CAPAs, ensuring inspection readiness and regulatory compliance across shifts while partnering with...RegulatoryShift work
$318k - $337.5k
## Senior Vice President, Cell Therapy Product Supply OperationsApplyremote... ...of the convergence of cell biology and genetic engineering. Our... .... This role oversees the strategy, execution, and continuous... ...Development, Analytical, Quality, Regulatory, Clinical Operations,...RegulatoryContract workWorldwide$200k - $300k
A biopharmaceutical company in Cambridge is seeking a Director or Senior Director of Regulatory Strategy. This role involves developing and implementing global regulatory strategies for clinical programs and leading interactions with regulatory authorities. Candidates...Regulatory- ...supports a growing portfolio of advanced cell and gene therapies (CGT), including CAR-T, iPSC, AAV,... ...and safety standards while meeting regulatory guidelines. Qualifications Education... ...: Bachelor’s or Master’s degree in Biology, Biotechnology, Molecular Biology, or...RegulatoryWork experience placementImmediate startFlexible hours
- Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC - Biologics to lead regulatory science for biologics assets across the development lifecycle. You will drive global CMC strategy, author submissions, and coordinate with Process Development, Analytical...Regulatory
$250k - $300k
...potential of engineered cells as medicines, who... .... As the Senior Director, Late-Stage Cell Therapy Process Development,... ...robustness, quality and regulatory compliance. Lead... ...execute a comparability strategy for pivotal process... ...of stem cell biology and 2D/3D stem cell...Regulatory$84k - $91k
Scientist - Gene Editing & Stem Cell Biology (Entry Level) - Eurofins USA PSS Insourcing Solutions... ...development of next‑generation cell therapies. Key Responsibilities Perform CRISPR‑... ...; maintain compliance with GMP and regulatory standards. Participate in raw material...RegulatoryFull timeCasual workMonday to Friday- ...Head of Regeneron Cell Medicines Location: Cambridge... ...RCM) sets the vision, strategy, and execution for... ...cell-based therapies. Based in Cambridge, MA... ...Development, Clinical, Regulatory, Quality, CMC, Manufacturing... ...MD, or MD/PhD) in cell biology, immunology, bioengineering...Regulatory
$238k - $374k
...dedicated group of experienced biologic drug hunters with the... ...articulate, and evolve the program strategy for antibody, bispecific, fusion... ...display, hybridoma, single B cell), lead optimization,... ...strong business acumen including regulatory (BLA/MAA pathway) and commercial...RegulatoryMinimum wageTemporary workLocal areaRemote work- Sana Biotechnology, Inc. is seeking a Senior Director to lead the company’s IP strategy in cell and gene therapy. You will draft and prosecute patents, manage global portfolios, and guide landscape analyses. Collaboration with R&D and external counsel is essential to align...
- ...Vice President of Biostatistics, Cell Therapy About the Company A rapidly growing, clinical... ...on influencing clinical development strategies and guiding the organization through the statistical aspects of global regulatory interactions and submissions. Applicants...Regulatory
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