Regulatory Affairs CMC Lead for Biologics & RNAi Therapies
Alnylam
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- ...Boston, is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative gene therapies. This leadership role requires extensive... ...experience in CMC regulatory requirements for biologics and gene therapies. The ideal candidate...SuggestedRemote workFlexible hours
$170k - $220k
...medicine company in Boston is seeking an Associate Director of Regulatory CMC to lead regulatory strategy and bridge development with regulatory roles. This hybrid position requires strong regulatory affairs experience in biotechnology, excellent communication skills,...Suggested- ...Eastridge Workforce Solutions is seeking a Senior Regulatory CMC Lead to provide strategic Regulatory CMC leadership for a global biologics program. This role will lead CMC activities supporting global BLA/MAA submissions, with a focus on Module 3, global regulatory strategy...SuggestedLocal areaRemote work
$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...Full timeTemporary workLocal areaFlexible hours$129k - $153k
...Regulatory LeaderCSL's R&D organization is accelerating... ...to developing therapies that make a... ...Global Regulatory Affairs Strategy Team (GRAST... ...regional, labeling and CMC GRAST members to... ...(including leading assigned tasks) while... ...degree in Pharmacy, Biology, Chemistry, Pharmacology...WorldwideRelocation package$230k - $250k
...Director, Global Regulatory Affairs - Strategy Lead Olema Oncology is a clinical-stage biopharmaceutical... ...approach to developing better therapies and passionate colleagues dedicated... ...regulatory requirements impacting drugs, biologics and devices Provide strategic...Work at officeFlexible hours2 days per week$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...Hourly payFull timeTemporary workLocal areaRemote workMonday to FridayShift work- ...SoTalent is seeking an Associate Director, Global Regulatory Affairs to influence global regulatory strategy for innovative therapies. This role is critical in shaping regulatory strategies and ensuring successful outcomes with cross-functional teams. The successful candidate...
- ...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...
- ...Takeda's Global Regulatory Affairs - CMC team in Cambridge, MA is seeking a Regulatory CMC professional to lead regulatory submissions for investigational, registration and post-approval programs across global markets. With minimal supervision, you will define CMC content...
- ...Vertex Pharmaceuticals is seeking an Associate Director, CMC Quality Compliance and Inspection Readiness to drive inspection readiness... ...through audits and CAPA closures. The position demands deep regulatory knowledge, experience with multiple modalities, and proven...
- ...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...Work at officeRemote workFlexible hours
- 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...
- ...Indianapolis, invites applications for Advisor/Sr. Advisor - Global Regulatory Affairs (GRA) – CMC Platform Regulatory Scientist. This role provides global... ...include developing global CMC regulatory strategies, leading preparation of CMC submissions, guiding cross-functional...
$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...$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$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$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
- ...Sci.bio Recruiting seeks a Computational Biology & Bioinformatics Lead to co-lead the computational protein science team. You will oversee ML and data systems supporting antibody and antigen discovery, protein characterization, neuroscience, lab automation, and operations...
$212k - $333.19k
...and delivers transformative therapies to patients. By focusing R&D... ...Leveraging a proven track record of leading at least 3 discovery... ...must include experience with biologics and preferably across... ...pharmaceutical industry, including regulatory requirements and commercial...Minimum wageFull timeLocal areaRemote workWorldwide$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$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$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- ...Planet Pharma is seeking a hands-on Regulatory Affairs leader to drive strategy and execution for a growing oncology pipeline. You will lead INDs, CTAs, amendments, and other submissions... ...with Clinical Development, CMC, Quality, and external partners to advance...
$130k - $300k
...Translational Medicine Lead, Oncology Therapy Area, R&D, Orion Corporation Are you a visionary... ...Subject matter expert in solid tumor biology, disease progression and treatment options... ...CDx lead, translational biology lead, regulatory and commercial to advance companion...Immediate start$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
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