Biologics CMC Regulatory Lead — Senior Director (Hybrid)
BioSpace
Beeline Medicines seeks a Senior Director, Regulatory Affairs CMC – Biologics to lead regulatory science for biologics assets, including monoclonal antibodies, from IND/CTA through BLA and post‑approval lifecycle. You will collaborate with Process Development, Analytical Sciences, Quality, and external CMOs to align with FDA/EMA expectations and global health authority standards. The role requires deep CMC regulatory expertise, strategic vision, and leadership to shape the regulatory #J-18808-Ljbffr BioSpace
$240k - $340k
...computational models, which leads to better drug designs,... ...seeking an exceptional Head of Biology to lead the scientific... ...VP level, or 7+ years for Senior Director level Drug-hunter track record... ...to understand and use regulatory, clinical and CMC considerations to inform TPP...SeniorRegulatoryFlexible hours$166.4k - $249.6k
...Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across... ...commercial products focusing on biologics. This role is accountable for authoring... ...and so much more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex...RegulatoryFull timeSummer workRemote workFlexible hours2 days per week$136.51k - $204.77k
...Job Title: Associate Director, CMC Lead Introduction to role: Are... ...IND/IMPD Readiness: Lead CMC regulatory strategy; guide and contribute... ...for IND/IMPD filings for biologics, conjugates, or complex... ...science makes possible. #LI-Hybrid Date Posted 04-Aug-2...RegulatoryHourly payTemporary work$202.13k - $336.88k
...approach to R&DPosition Summary:As the Senior Director, Early Phase CMC Medicine Research Leader you will... ...recruiting of CMC project matrix leaders who lead programs in support of Early... ..., supply chain, quality and CMC regulatory strategy through leadership of the CMC...SeniorRegulatoryFull timeLocal area$212k - $333.19k
...true to the best of my knowledge.Job DescriptionSenior Director, AIRx Discovery Biology Lead Takeda Research is constructing the Discovery Automation... ...Cambridge, MA. This position is currently classified as “hybrid” by Takeda’s Hybrid and Remote Work policyTakeda Compensation...SeniorMinimum wageTemporary workLocal areaRemote work$242.25k - $403.75k
Job Title: Senior Director, Portfolio Integration Lead - Hematology Overview Cancer is unrelenting... ...understanding of disease biology and deliberate scientific... ...authority interactions, regulatory submissions and key... ...Arrangement This role offers a hybrid working model, with a mix...SeniorRegulatoryLocal areaRemote workWork from home- ...teams. The role focuses on analytical methods for excipients, raw materials, and process-related impurities, with strong emphasis on regulatory readiness and method lifecycle management. The ideal candidate has 7+ years in analytical method development or 5+ years with a...SeniorRegulatoryContract work
$242k - $313.5k
...developing and delivering category‑leading precision therapies to transform... ...life fully. Job Summary The Senior Director, Regulatory Affairs CMC - Biologics provides senior‑level scientific... ...infrastructure. Work Arrangement & Location Hybrid - This position follows a hybrid...SeniorRegulatoryLocal areaFlexible hours2 days per week- ...Therapeutics, based in Boston, is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative gene therapies... ...extensive experience in CMC regulatory requirements for biologics and gene therapies. The ideal candidate will have...RegulatoryRemote workFlexible hours
$235k - $285k
...our One Team culture thrive. Join us as a Senior Director, CMC Technical Lead , and you’ll be part of a culture that... ...functional teams, external partners, and regulatory authorities to ensure successful development of biologics on the Hypercon Platform. The role requires...SeniorRegulatoryTemporary workLocal area- A public Biotech company in Boston is seeking a Regulatory Affairs CMC Manager/Senior Manager to support biologic products' global development and registration. The ideal candidate will lead the submission of regulatory documentation, ensuring compliance with FDA and EMA...Regulatory
- ...DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and... ...and Skills:Knowledge of regulatory requirements and inspection expectations... ...or leanProven ability to lead improvement projects and... ...travel possible Hybrid-Eligible RolesIn this Hybrid-...RegulatoryFull timeSummer workRemote workFlexible hours2 days per week
- Vertex is a global biotechnology company seeking an Associate Director in CMC to lead global regulatory strategies for biologics, authoring and reviewing submissions, and serving as the primary CMC interface with Health Authorities. The role emphasizes AI-enabled regulatory...Regulatory
- ...Switzerland GmbH in Cambridge, MA is seeking an Associate Director, Regulatory Affairs CMC to lead the development and execution of global regulatory... ...proven regulatory leadership. The position allows for hybrid work arrangements, reflective of Alnylam's commitment to...Regulatory
$195k - $330k
...focused on building an industry-leading pipeline of oral small... ...make an impact:Drive end-to-end CMC program management for mid to... ...product, analytical, quality, regulatory, and supply chain workstreams... ...M.S.) of CMC experience; Sr. Director level requires commensurate additional...SeniorRegulatory- Alkermes is seeking a Senior Manager of Regulatory Affairs to guide regulatory strategies for new product development and clinical progression, reporting... ...collaboration, and responses to authorities, with a hybrid work model and onsite presence in Waltham, MA. #J-18808-...SeniorRegulatory
- Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory...SeniorRegulatory
$214.9k - $358.1k
...autonomy, you will partner with senior Medical, Development, Digital,... ...technology for its own sake. Lead the design, piloting, and... ...interpret evolving US and global regulatory, legal, privacy, and ethical guidance... ...LOCATION ASSIGNMENT This is a hybrid role requiring you to live...SeniorRegulatoryPermanent employmentH1bLocal areaVisa sponsorshipWork visaRelocation package2 days per week$195k - $330k
...immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new... ...study reports, consent forms; abstracts and/or manuscripts and regulatory documents (e.g. IND, IB etc.)Builds biomarker knowledge base...SeniorRegulatory$200.39k - $250.33k
Ionis Pharmaceuticals, Inc. is seeking a Director of Computational Biology in Boston to lead target identification and multi-omics research. This role requires a PhD and 8+ years of experience in the field, with a proven track record in multi-omics approaches. Responsibilities...Remote job$173k - $285.33k
...outcomes. What You'll Do As a Director/Senior Director, CMC Drug Substance Development, you will... ..., CMC, you will design, execute, and lead chemical process development and manufacturing... ...review drug substance sections of regulatory documents. You will: Lead Drug...SeniorRegulatory$170.9k - $231.3k
Overview The Associate Director, Regulatory Affairs CMC Development is responsible for... ...scientific foundation in biologics and/or complex modalities,... ...landscape.This position is hybrid and primarily located in... ...authority briefing packages.Lead or help to lead the...RegulatoryFull timeTemporary workWork at officeLocal areaFlexible hours$193.1k - $289.7k
...GENERAL SUMMARY The CMC Statistics Director (Scientific Fellow) provides... ...quality control, and regulatory submissions. This... ...will establish and lead the CMC Statistics capability... ...methodologies across biologics, cell and gene... .... Flex Designation: Hybrid-Eligible Or On-Site Eligible...RegulatorySummer workRemote workFlexible hours2 days per week- Director / Sr. Director, Nonclinical Toxicology & PK (Remote/Hybrid) Pinetree therapeutics 26.11.05 Location: Cambridge... ...is a tox-first, biology-driven drug developer... ...the nonclinical safety lead on cross-functional... ...ensuring data quality and regulatory alignment. PK &...SeniorRegulatoryRemote job
- ...Job Description Job Description Scientist/Senior Scientist, Biology Lead – Kidney Experience About the Role We are seeking a highly motivated... ...closely with chemistry, delivery, translational, regulatory, and external teams · Help define scientific strategy...SeniorRegulatory
$210k - $290k
...bold, highly collaborative Senior Director to lead Protein Analytics & Biophysics... ...readouts, synthetic biology, automation, microfluidics,... ...Machine Learning, Biology, and CMC/Tech Ops, and translating an... ...biology.Familiarity with regulatory expectations and analytical...SeniorRegulatoryShift work$210.4k - $331.1k
...QP2 Oncology) team as Senior Director, Quantitative Systems... ...Primary Responsibilities Lead and shape the QSP... ...Ensure high-quality, regulatory grade QSP deliverables... ...pharmacology, systems biology, PKPD, mathematics, chemical... ...the position will be hybrid. Please note that...SeniorRegulatoryFull timeContract workFor contractorsLocal areaRemote workRelocationVisa sponsorshipFlexible hoursShift work- ...which would support regulatory submissions... ...understanding of ion channel biology, and expertise in... ...an experienced Senior Manager/Associate Director, Quality Control to lead Quality Control... ...industry experience. Hybrid positions require... ...checks on the CMC sections of regulatory...SeniorRegulatoryTemporary workWork at officeRemote work2 days per week
- ..., and success metrics for AI investments Lead design, piloting, and scaled deployment of... ...teams Interpret evolving U.S. and global regulatory, legal, privacy, and ethical guidance on... ...Experience with vendor and partner management and senior cross-functional matrix teams Candidates...SeniorRegulatoryPermanent employment
$238k - $374k
...group of experienced biologic drug hunters with... ...resources of a leading pharmaceutical company... ..., clinical, CMC, and commercial considerations... ...science to senior governance... ...acumen including regulatory (BLA/MAA pathway)... ...currently classified as “hybrid” by Takeda’s Hybrid...RegulatoryMinimum wageTemporary workLocal areaRemote work
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