Senior Regulatory Operations Lead (Biotech)
Prime Medicine, Inc.
Prime Medicine, Inc. is seeking a Senior Manager of Regulatory Operations to plan, coordinate, and drive global submissions across our product pipeline. You will partner with Regulatory Affairs, CMC, Nonclinical, Clinical, Quality, and external vendors to ensure complete, high-quality submissions are delivered on schedule. The role requires strong project management and deep knowledge of regulatory submission processes across the FDA and EMA. #J-18808-Ljbffr Prime Medicine, Inc.
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Operations Lead (Biotech) in Cambridge, MA vacancy
- Metaphore Biotechnologies, Inc. is seeking a Senior Director of Clinical Operations to lead hands-on execution of early clinical development for the company... ..., including CRO/vendor oversight, site strategy, regulatory coordination, and global start-up, with focus on Phase...SeniorRegulatory
- Planet Pharma is seeking a Senior Clinical Trial Manager in... ...Cambridge, MA area to oversee operational aspects of clinical... ...vendors, and may serve as Lead CRA as needed. The role requires 5+ years of biotech/pharma experience, strong regulatory knowledge and excellent communication...SeniorRegulatory
- Scorpion Therapeutics is seeking a Lab Operations Manager to oversee laboratory facilities and processes within a biotech setting focused on genetic medicines and lipid nanoparticle... ...management experience, a strong grasp of regulatory standards, and proficiency with lab software...Regulatory
- As a Senior Scientist Immunology overseeing the design and execution... ...cell biology, and support regulatory filing with authoring of technical... ...general business and people operations, as needed.Qualifications·... ...in drug development in biotech or pharma setting, with research...SeniorRegulatory
Cedent Consulting
Boston, MA4 days ago - ...Role Senior Corporate Counsel supporting Ginkgo's biotech and synthetic biology operations, focusing on commercial transactions, partnerships, and supply chain legal frameworks... ...biology companies familiarity with regulatory, GxP, or patent issues in the life sciences...SeniorRegulatory
Scorpion Therapeutics
Boston, MA1 day ago $115k - $215k
...building an industry-leading pipeline of oral small... ...recommendations to project teams, senior leadership, and... ...industry or startup biotech setting; or BS/MS with... ...preclinical species.Operation, maintenance, and troubleshooting... ...documentation for regulatory submissions, with...SeniorRegulatoryKymera Therapeutics
Watertown, MA3 days ago- Aurion Biotech, Inc. in Cambridge, MA is seeking a Senior Scientist, Analytical Science & Technology to lead method transfers and validations at external CDMOs. You will author and... ...review protocols, evaluate data, and ensure regulatory compliance for QC testing of cell...SeniorRegulatoryRemote job
$119.7k - $222.3k
...Sciences representative to lead the development and... ..., scientific and operational leadership. They would... ...and interactions with regulatory agencies, as appropriateProactively... ...(academia, CRO, biotech or Pharma).2+ years of... ...to be considered for Senior Principal Scientist....SeniorRegulatoryFull timeNovartis
Somerville, MA1 day ago- ...The Position Senior Principal Statistician A healthier future... ...pipeline and promote regulatory success - ultimately bringing... ...methodological communities You lead statistical design and strategy... ...within the pharmaceutical, biotech, or healthcare sector You...SeniorRegulatoryLocal area
Genentech
Boston, MA15 hours ago - Aurion Biotech in Cambridge, MA, is seeking a Senior Scientist in Analytical Science & Technology to lead method transfers and validations at external CDMOs. You will author and review... ...experience and a strong pharmaceutical regulatory mindset. You will interface with...SeniorRegulatory
- ...Corporation in Cambridge, MA seeks a Senior Scientist, Process... ...commercial manufacturing. You will lead development strategies,... ...understanding, and contribute to regulatory documentation. The role... ...cell therapies in a fast-paced biotech environment. #J-18808-Ljbffr...SeniorRegulatory
- ...Biomedicines in Cambridge, MA seeks a Senior Scientist for Analytical Development and Quality Control. You will lead method development for nucleic acid... ...products, mentor junior staff, and support regulatory filings in a fast-paced biotech setting. We value hands-on bench work...SeniorRegulatory
$190k - $240k
...Territory US Reporting to: Senior Director, Medical... ...as a team mentor, and lead national level initiatives... ....· Build thorough operational understanding to ensure... ...internal and external regulatory and legal guidelines.·... ...MSL role within the biotech or pharmaceutical industry...SeniorRegulatoryFull timeLocal areaRemote workOrchard Therapeutics
Boston, MA3 days ago- ...Senior Quality Engineering Specialist at a gene-editing biotech company provides operational support for GxP-regulated software, equipment, and vendor oversight. The role executes... ...requirements Strong understanding of regulatory compliance and inspection readiness...SeniorRegulatory
Prime Medicine
Cambridge, MA6 days ago - Real Staffing Group in Massachusetts seeks a Senior Planner, Materials Management to join a leading biotechnology organization. The role ensures material availability... ...Planning, Manufacturing, Quality, Development, Regulatory, Clinical, and Commercial teams to translate demand...SeniorRegulatory2 days per week
- Quotient Therapeutics is seeking a Senior Director of Business Development to lead partnering, asset in-licensing, and market intelligence, reporting to... ...to-end deals, and collaborate across R&D, clinical, regulatory, and executive teams in a fast-paced, early-stage setting...SeniorRegulatory
$138k - $184.5k
...Biogen seeks a Senior Scientist for parenteral drug product development... ...through commercial stages Lead sterile parenteral drug... ...protocols, validation documents, and regulatory submission materials... ...related field with 4+ years pharma/biotech experience Demonstrated...SeniorRegulatoryBiogen
Cambridge, MA6 days ago- ...Immune Medicines in Watertown, MA is seeking a Senior Accountant to own the monthly close, cash... ...strengthen financial controls, support audits and regulatory filings, and help scale the finance function within a growing biotech company. The role emphasizes collaboration,...SeniorRegulatoryWork at office
- ...Senior Vice President of Regulatory Sciences About the Company Innovative biotechnology (BioTech) company specializing in mRNA therapeutics Industry... ...for building and leading the regulatory sciences... ...on global strategy, CMC, operations, and vendor management....SeniorRegulatory
$210k - $320k
...Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To... ...changes, and secondary suppliers.Work directly with regulatory and key stakeholders on the development and implementation of...SeniorRegulatoryFull timeBeam Therapeutics
Somerville, MA2 days ago$171.3k - $256.9k
Job DescriptionThe Senior Medical Science Liaison (... ...development/clinical operations by fully understanding... ...as the “MSL congress lead” through organizing and... ...understanding of the healthcare regulatory environmentProficient... ...roles in the pharma/biotech industry or the...SeniorRegulatoryFull timeSummer workWork at officeLocal areaVertex Pharmaceuticals
Boston, MA3 days ago$109.2k - $273k
...generate evidence that informs regulatory, safety, and clinical... ...clinical development programs. The Senior Epidemiologist will collaborate... ...working within pharma or biotech, and a thorough understanding... ...healthcare.Work hand-in-hand with one leading sponsor, gaining deep...SeniorRegulatoryFull timePart timeImmediate startRemote workWorldwideIQVIA
Boston, MA15 hours ago$88k - $132k
...Materials Management Warehouse Senior Specialist to oversee warehouse operations and inventory logistics... ...aligned with regulatory and operational best practices... ...service providers and lead vendor performance reviews... ...pharmaceutical or biotech manufacturing ~ Proficiency...SeniorRegulatoryVertex Pharmaceuticals
Boston, MA6 days ago$145k - $195k
...performance for life.As a Senior Clinical Scientist, you will... ...development, product innovation, and regulatory objectives. Operating with minimal oversight, you... ...requires someone who can lead their assigned workstreams,... ..., SaMD, pharmaceutical, biotech, or real-world evidence...SeniorRegulatoryFull timeWork at officeRemote workRelocationWHOOP
Boston, MA2 days ago$126k - $165k
...experimental records and ensure compliance with institutional and regulatory guidelinesQualificationsPh.D. in Molecular Biology, Cell... ...gene silencing, protein over-expression)Experience working in a biotech or pharmaceutical settingAbout FlagshipFlagship Pioneering is...SeniorRegulatorySeres Therapeutics
Somerville, MA3 days ago$82.01k - $113.3k
...Company Overview: Prime Medicine is a leading biotechnology company dedicated to... ...defined clinical development and regulatory path, and each expected to provide the... ...We are seeking a highly motivated Senior Laboratory Operations Associate with 3–5 years of hands-on...SeniorRegulatoryFull timeTemporary workPrime Medicine, Inc.
Watertown, MAmore than 2 months ago- Summary The Senior Director, Regulatory Affairs leads and coordinates regulatory interactions and submission execution... ..., Quality, Nonclinical, Clinical Operations, and other contributors to develop... ...affairs experience in the biotech or pharmaceutical industry, including...SeniorRegulatoryContract work
$126.07k - $170.56k
...helped pioneer the world of biotech in our fight against the world... ...your career.Process Development Senior ScientistWhat you will doLet’... ...using mass spectrometry.May lead activities and method... ...and Controls (CMC) sections in regulatory documents.May lead and mentor...SeniorRegulatoryHourly payFull timeContract workFlexible hoursAmgen
Somerville, MA2 days ago$110.7k - $218.3k
Position Summary Senior Consultant - Product Quality... ...& Healthcare Enterprise Operations & Risk Our Deloitte Regulatory, Risk & Forensic team... ...professional client baseExperience leading/mentoring a cross... ...experience in the Pharmaceutical, Biotech and/or Medical Device...SeniorRegulatoryLocal areaDeloitte
Boston, MA15 hours ago$131k - $198k
...Salesforce Life Sciences Cloud, Senior ConsultantOur Deloitte... ...strategists, data scientists, operators, creatives, designers,... ...workforce.An evolving customer and regulatory landscape, mounting... ...industry (pharma, medtech, or biotech)3+ years leading Salesforce programs,...SeniorRegulatoryLocal areaVisa sponsorshipDeloitte
Boston, MA4 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Operations Lead (Biotech). Be the first to apply!
Related searches
- operations lead Cambridge, MA
- operations leader Cambridge, MA
- senior safety specialist Cambridge, MA
- senior service designer Cambridge, MA
- senior mulesoft developer Cambridge, MA
- senior media manager Cambridge, MA
- senior business manager Cambridge, MA
- senior linux systems engineer Cambridge, MA
- senior mainframe developer Cambridge, MA
- senior cloud security engineer Cambridge, MA