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)
$80k - $110k
...scientific breakthroughs into transformative therapies and get them quickly, safely and... ...clinical trials and navigated payor and regulatory systems to deliver patient impact — and... ...Associate/Senior Research Associate in Cell Biology and Immunology to join our growing team...Regulatory- AstraZeneca GmbH in Boston, MA is seeking a Director of Regulatory Affairs Strategy for Cell Therapy to lead global regulatory strategy across oncology, immune-mediated and rare diseases. You will drive Health Authority engagements, submissions, and labeling, mentor cross...Regulatory
- Voisin Consulting SARL is seeking a Senior Director of US Regulatory Strategy in Boston to lead regulatory guidance for biotech and pharmaceutical... ...of BLA submissions, with a focus on complex biologics and therapies, emphasizing strong client relationships and business...Regulatory
$67.6k - $80k
...Fellow Position – Stem Cells, Aging and Genome... ...Cell and Regenerative Biology Position Description... ...develop new gene and cell therapies for currently... ...technologies #Developing strategies to induce immune tolerance... ...applications, and regulatory/compliance documents....Regulatory- ...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
- ...effective and safe therapies for the treatment... ...Business Insights & Strategy will help build... ...Reporting to the Senior Director of Business... ...differentiation, and regulatory pathway. Build... ...internal governance (Exec/Board). Develop and... ...of cancer biology, clinical trials,...RegulatoryRemote work
- ...International is seeking a Senior Manager/Associate Director for Global Regulatory Affairs CMC in Boston, MA. This key position involves supporting regulatory strategy and execution for innovative biologic therapies. The ideal candidate will have extensive experience in...Regulatory
- 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
- 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
- ...optimization, and qualification of cell-based potency assays that evaluate the biological activity of cell therapy products. Design and... ...packages, specifications, and regulatory support documents.... ...Regulatory to advance analytical strategies throughout product development...RegulatoryContract work
- AstraZeneca GmbH is seeking an Associate Director - Territory Operations Manager in Boston, MA to lead the cell therapy division. The role involves establishing service... ...clinical operations, and ensuring compliance with regulatory standards. The candidate should have 8+ years...Regulatory
$113k - $155k
...create and deliver life-changing therapies by accelerating research,... ...solutions and services support biologics manufacturers from research... ...ensuring quality, efficiency and regulatory compliance at every stage.... ...Technical Sales Specialist, Cell Culture, BioProduction, where...RegulatoryTemporary workWork at officeRelocation package3 days per week$175k - $200k
...field of targeted radioligand therapy. To accomplish this, we... ...motivated and experienced Associate Director in Biology to join a growing team of... ..., pharmacokinetics) in cell line and patient‑derived xenografts... ..., clinical, and regulatory, to ensure successful project...RegulatoryWork experience placement- ...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
$80.3k - $131.1k
...discovery research team at Regeneron Cell Medicines. You will be... ...studies that support regulatory submissions. We hope you are... ...development of CAR/TCR T cell therapies in solid tumor indications Characterizing... ...BS/MS in immunology, cell biology or related field and at least...Regulatory- BioSpace is seeking a Senior Director of Regulatory Affairs in Boston. The role involves planning and executing regulatory strategies for gene-editing programs, managing submissions... ...regulatory affairs. Candidates with complex biologics experience are preferred. #J-18808-...Regulatory
- VCLS, a regulatory consulting firm, seeks an experienced Senior Director or Executive Director of US Regulatory Strategy in Boston to provide strategic regulatory guidance to biotech and... ...clients developing innovative therapies. Lead US/global regulatory strategy,...Regulatory
- Compliance Specialist, Cell Therapy Manufacturing (Cambridge, MA) The Compliance Specialist provides support for projects, manufacturing... ...the execution of validation protocols. May participate in regulatory inspections and/or the implementation of corrective actions arising...RegulatoryWork at officeWeekend workAfternoon shift
- Head of Regeneron Cell Medicines Location: Cambridge... ...RCM) sets the vision, strategy, and execution for... ...transformative cell‑based therapies. Based in Cambridge,... ..., Clinical, Regulatory, Quality, CMC, Manufacturing... ...MD, or MD/PhD) in cell biology, immunology, bioengineering...Regulatory
$170k - $210k
...is seeking an MSAT Associate Director. This role involves leading a... ...responsible for the pancreatic cell maturation and aggregation... ...years of experience in cell therapy manufacturing. The position requires... ...skills along with regulatory compliance. The base pay range...Regulatory$197.4k - $246.8k
...women's health, rare diseases, cell & gene therapies and CNS. With several... ...LinkedIn. Job Overview The Director of New Product Planning (... ...Executive Director, R&D Strategy and New Product Planning, and... ...positioned for clinical, regulatory, and commercial success, while...RegulatoryWork experience placementWork at officeRemote workFlexible hours- ...Vice President, Biometrics, Cell Therapy About the Company Rapidly growing clinical-stage... ...focus on influencing clinical development strategies and guiding the organization through the statistical aspects of global regulatory interactions and submissions. Applicants...Regulatory
- ...leading biotechnology company in Boston seeks a Senior Director of Manufacturing Technical Sciences Quality Assurance. This hybrid role involves overseeing quality for cell and genetic therapies, ensuring regulatory compliance, and leading a team across all stages of...RegulatoryFlexible hours
- Vertex Pharmaceuticals seeks a Director of Analytical Product Quality in Boston. This role involves... ...oversight in analytical development for Cell & Gene therapies, ensuring compliance with internal procedures and regulatory standards. The ideal candidate will have 10+...Regulatory
- ...Analytical Development in Cambridge, MA, to execute assays for cell therapy products. The role encompasses conducting independent... ...collaborating with various teams, and authoring technical documents for regulatory submissions. Candidates should have a PhD or MS in related...Regulatory
- ...title: US Senior Medical Director, Rare Hematology... ...Anemia (wAIHA), and Sickle Cell Disease (SCD) among... ...Affairs, Clinical Research, Regulatory, Science, Marketing,... ...Medical Strategy & Leadership Develop... ...regarding rare hematology therapies Review Educational Outreach...Regulatory
- ...Clinical Development, Haematology and Cell Therapy About the Company Forward-thinking... ...leading the global clinical development strategy across hematology and transplant/cell... ...Phase 1-3 clinical trials, and leading regulatory strategy and global health authority interactions...Regulatory
$238k - $374k
...dedicated group of experienced biologic drug hunters within AIRx that... ..., 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- ...Scientific Associate to advance scalable upstream/downstream processes for cell and gene therapy. You will perform stem cell expansion in bench bioreactors, document protocols, and contribute to regulatory filings with a data‑driven approach. The role requires DoE/QbD...Regulatory
- ...Associate in Boston to advance scalable upstream or downstream cell and gene therapy processes from bench to commercial scale. You will apply... ..., document data, and collaborate across teams to meet regulatory milestones with emphasis on cGMP implementation and data integrity...Regulatory
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