Regulatory Affairs CMC Lead for Biologics & RNAi Therapies
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals is seeking an Associate Director of Regulatory Affairs CMC Development to shape global CMC regulatory strategies for development-stage programs, with emphasis on oligonucleotide-based modalities. The role bridges Research, Development, and Regulatory Sciences, requiring strong communication and strategic thinking. This hybrid position is based in Cambridge, MA or Philadelphia, PA, offering a comprehensive benefits package. #J-18808-Ljbffr Alnylam Pharmaceuticals
$177k - $278.08k
...and delivers transformative therapies to patients. By focusing R&D... ...therapies, including ADCs, complex biologics and small molecules. Our... ...as a Director, Global Regulatory Lead Oncology where you will be part... ...concepts within regulatory affairs and implications across the...SuggestedMinimum wageLocal areaRemote workWorldwide$237.7k - $356.5k
...The Senior Director, CMC Product Leader (T1D) will lead the Chemistry,... ...team supporting cell therapy products within Biopharmaceutical... ..., validation, regulatory submission, and... ...with Regulatory Affairs and Quality to... ..., or other complex biologic productsStrong understanding...SuggestedFull timeSummer workRemote workFlexible hours2 days per week$161.5k - $218.5k
...purification as well as lead program(s) with the... ...transition by leading CMC team as necessary for the... ...Formulation Development, Regulatory, Technical Operations,... ...for programs beyond core RNAi.This position is onsite... ...as CMC team lead for biologics or complex/hybrid modalities...SuggestedFull timeTemporary workLocal areaFlexible hours$145 - $170 per hour
...find your next opportunity. Senior Regulatory CMC Lead Compensation: $145.00 - $170.00 Loading... ...our client’s global Regulatory Affairs team. Created/Revised Date : September... ...Regulatory CMC leadership for a global biologics program. This role will lead CMC activities...SuggestedHourly payFull timeTemporary workLocal areaRemote workMonday to FridayShift work- ...Description Primary Responsibilities 1. Global Regulatory CMC Strategy Lead and drive the global Regulatory CMC strategy for biologic ADC programs. Provide strategic guidance... ...10 years of experience in Regulatory Affairs CMC within the biotechnology and/or...SuggestedWork at officeRemote workFlexible hours
- Moderna seeks an Associate Director of Global Regulatory Affairs, CMC, to lead LATAM regulatory activities and ensure high-quality CMC submissions. This role oversees agency communications, and regulatory applications, coordinating cross-functional teams in a fast-paced...
- Scholar Rock is seeking an Associate Director, Regulatory Strategy in the greater Boston area to lead the development and execution of regulatory plans for clinical... ...pipeline programs. This role represents regulatory affairs on cross-functional teams and directs submissions...
- ...Takeda in Boston, MA is seeking an experienced GRA CMC Product Lead to develop and oversee regulatory CMC strategies for assigned products, guiding submissions from development through lifecycle. You will represent Regulatory, Pharmaceutical Development, and Commercial...
$237k
...Pharmaceuticals seeks a Senior Director to lead Chemistry, Manufacturing, and Controls strategy for Type 1 Diabetes cell therapy products. The role involves developing integrated CMC plans across development, scale-up, regulatory submission, and commercialization while...$122.25k - $176.58k
Job Title: CMC Demand & Supply LeaderLocation: Framingham... ...Projects in respect to Regulatory and Quality... ...and budget definition.Co-lead Demand & Supply Sub Team... ...Immuno-inflammation, Gene Therapy, Rare Diseases,... ...Biochemistry, Molecular Biology, Biotechnology, Biomedical...Full time$204k - $281k
About This Role:As the CMC Asset Lead, you will be an integral part of the PO&T Nephrology team, focusing on the development and launch of Biogen's nephrology assets. Your initial focus will be on overseeing a critical asset in clinical development for multiple indications...Full timeTemporary workLocal area$151.2k - $226.8k
...genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.This includes... ...for QMS health (cycle time, overdue items, training compliance)Lead QMS simplification/optimization, including CAPA prevention initiatives...$142.5k - $256.5k
The RoleThe Global Regulatory CMC Lead will be responsible for coordinating regulatory CMC activities for one or more products, depending on... ...What You’ll Need (Basic Qualifications)BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely...Permanent employmentFull timeWork at officeWork from home- ...recruit an experienced Global Asset Lead (GAL) to take end‐to‐end accountability... ...integrating the efforts of Clinical, Regulatory, CMC, Medical Affairs, and Commercial functions.Your... ...into new indications, earlier lines of therapy, and novel combination regimens (e.g....Shift work
$196.7k - $353.4k
...Director, Translational Medicine Lead - Autoimmune. This individual... ..., pathogenic T- and B-cell biology, immune-cell depletion and... ...approaches to evaluate pathogenic and regulatory T-cell biology, B-cell states... ...-in-class immunomodulatory therapies.Experience with mRNA...Permanent employmentFull timeWork at officeWork from home$212k - $333.19k
...information I submit in my employment application is true to the best of my knowledge.Job DescriptionSenior Director, AIRx Discovery Biology Lead Takeda Research is constructing the Discovery Automation & Robotics (DAR) group built on AI, automation, new ways of working,...Minimum wageLocal areaRemote work$185.5k - $344.5k
...PK Sciences representative to lead the development and use of... ...potentially includes small molecules, biologics/therapeutic proteins,... ...drug-conjugates, radioligand therapies and/or cell therapies across... ...organization and interactions with regulatory agencies, as...Full timeRemote work$163k - $225k
...Technology (PO&T) Division is looking to hire a CMC Asset Lead. This Associate Director level Asset... ...CMC aspects of clinical programs in biologics, pharmaceuticals or other modalities.... ...chain, device (if applicable) and regulatory CMC, in the development of and delivery...Temporary workLocal area$216.4k - $324.6k
...seeking a scientific and technical expert to lead our agentic AI co-scientist initiative... ..., Machine Learning, Computational Biology, Computational Chemistry, Bioinformatics,... ...and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease,...Summer workRemote workFlexible hours2 days per week3 days per week- ...Takeda in Boston, MA is hiring a Business Lead for AI-native Large Molecule Discovery to own a strategic product family spanning discovery... ...and business value. This hybrid role requires deep biologics discovery experience, leadership across Research, DD&T, and external...
- ...Biogen, Inc. is seeking a CMC Asset Lead for the PO&T Nephrology team to oversee a critical asset across indications, including three Phase 3 studies, with commercialization targeted for 2028–2030. You will drive asset strategy, launch planning, lifecycle management...
$154.4k - $242.55k
...DescriptionThe Plasma-Derived Therapies (PDT) R&D Organization is... ...MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma... ...regulatory strategy, medical affairs, etc.). 5-7 years of... ...plasma-derived therapies and biologics preferred.Bachelor’s or Master...Minimum wageLocal area- Relay Therapeutics is recruiting for an Associate Director/Director, CMC Regulatory in Cambridge, MA. You will lead regulatory CMC strategies for small molecule programs, develop global submission plans, and coordinate cross-functional teams to ensure regulatory success...
- Biogen, Inc. in Cambridge, MA (hybrid) seeks a CMC Commercial Asset Development Lead to guide asset strategy, development, supply, and lifecycle planning across PO&T. This high-impact role influences asset value and portfolio decisions with cross-functional leadership across...
- Hongene Biotech is seeking an Associate Director / Senior Manager in CMC Project Management in the Boston area. The role reports to the VP, Global Head of CMC & Regulatory and strengthens project management for oligonucleotide contract manufacturing services. Senior/AD...Contract work
- ...seeks a Director of Immunology Scientific Innovation to lead a laboratory-based team and drive discovery in immune-mediated... ...outside the Boston area. The role combines disease biology, immunology, and cell therapy strategies to shape translational programs and mentor...Relocation3 days per week
$130k - $300k
Translational Medicine Lead, Oncology Therapy Area, R&D, Orion Corporation Are you a visionary scientist... ...Subject matter expert in solid tumor biology, disease progression and treatment... ...CDx lead, translational biology lead, regulatory and commercial to advance companion diagnostic...Immediate start$168k - $220.5k
...collaborative, and proactive Patent Counsel, Biology to join our Intellectual Property team,... ...Intellectual Property, Ethics & Legal Affairs, Contracts & Partnering, and Research functions... ...practice. Technical expertise in cell therapy or stem cell technologies. Strong...Private practiceWork at officeLocal area$1,000 per month
A local educational organization is seeking a part-time Club Advisor for Marine Biology at Cambridge Rindge & Latin High School. The role involves meeting regularly with club members, managing club funds, and supervising activities. Ideal candidates should have knowledge...Price workContract workPart timeLocal area$307k - $325.35k
...operated subsidiary of Bayer AG, is a leading engineered cell therapy company pioneering a new generation... ...of the convergence of cell biology and genetic engineering. Our mission... ...concept and beyond. Integrate clinical, regulatory, CMC, nonclinical, safety, commercial,...WorldwideShift work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs CMC Lead for Biologics & RNAi Therapies. Be the first to apply!
- regulatory engineer Cambridge, MA
- regulatory scientist Cambridge, MA
- clinical research regulatory Cambridge, MA
- regulatory technician Cambridge, MA
- regulatory cmc Cambridge, MA
- regulatory Cambridge, MA
- regulatory executive Cambridge, MA
- regulatory law Cambridge, MA
- regulatory contract Cambridge, MA
- food regulatory Cambridge, MA



