Senior Regulatory Inspection Lead
Initial Therapeutics, Inc.
Initial Therapeutics, Inc. in Cambridge, Massachusetts is looking for a Regulatory Affairs Specialist focused on planning and supporting regulatory inspections. The role involves ensuring compliance with Health Authority Regulations through various activities such as planning inspections and providing guidance for regulatory findings. The ideal candidate will have a BS/BA, MS or PhD with extensive experience in biotech or pharma. The position offers extensive healthcare coverage and a generous PTO policy. #J-18808-Ljbffr Initial Therapeutics, Inc.
$178.1k - $244.86k
...ensuring alignment with enterprise priorities, regulatory requirements, and product lifecycle... ...access globallyACCOUNTABILITIES Lead end-to-end strategy development and execution... ...and SOPs, including supporting audit and inspection readinessMonitor and manage program budgets...SeniorRegulatoryMinimum wageTemporary workLocal areaNight shift- 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
- Treeline in Watertown, MA is looking for a Senior Manager, Clinical Data Management who... ...with CROs, manage external vendors, and lead process optimization efforts. The ideal candidate... ...in oncology, and a solid grasp of regulatory guidelines. This role entails mentoring junior...SeniorRegulatory
$167k - $260k
...offers a hybrid work schedule. The Wells Fargo job profile is Senior Lead Communications Consultant.In this role, you will:Serve as a... ...content supporting talent programs, systems enhancements, and regulatory change initiativesAdvise on high-impact or sensitive communications...SeniorRegulatoryFull timeWork experience placement- Regeneron Pharmaceuticals, Inc. in New York seeks a Senior Toxicologist to lead nonclinical development programs with guidance from a supervisor... ...ability to independently design, conduct, and interpret regulatory toxicology studies in rodent and non-rodent models,...SeniorRegulatory
- ...sciences management firm, seeks a Viral Vector Analytics Group Lead for a 3‑month onsite contract in the greater Boston area. You will... ...for viral vectors, oversee assay development, and ensure regulatory‑compliant QC readiness, working with internal and external partners...SeniorRegulatoryContract work
$105.8k - $175k
...transform the world for good. Your impact We are seeking a Senior Environmental Permitting Lead to drive the successful planning, siting, and... ...lead responsible for environmental permitting strategy, regulatory interface, and high-quality technical deliverables, with...SeniorRegulatoryFull timeLocal areaRemote workShift work$212k - $333.19k
...to accelerate access to transformative medicines and make a lasting impact on patients worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of the global regulatory team. In this influential role, you will lead a top-priority...SeniorRegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide- A healthcare technology company is seeking a Sr. Regulatory Affairs Specialist in Somerville, Massachusetts, to support the commercialization of its digital products and AI technologies. The role involves providing regulatory input on product development, maintaining compliance...SeniorRegulatoryRemote job
$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- ...a Manager-level Programmer to provide timely support for the study team on all programming matters, leading programming deliverables from data processing to regulatory submission. This onsite role in Cambridge involves overseeing code, logs, and outputs in a regulated...SeniorRegulatory
$170k - $252.5k
...Who we are looking for:As the Client Pod Senior Lead, you will have end to end accountability for the AOIA client service experience... ...and new business governance. Actively manage operational and regulatory risk, ensuring compliance with internal policies and external...SeniorRegulatoryFull timeTemporary workFlexible hours- Integra LifeSciences Sr. Quality Inspector will support QC Incoming Inspection and Review & Release activities to ensure compliance with internal procedures, regulatory requirements, and quality standards. The role acts as a technical resource across QC and Release, collaborating...SeniorRegulatory
$136.4k - $253.2k
...Data Science is recognized as a leading hub for top industry talent,... ...agile workforce to deliver regulatory commitments across the portfolio... ...Program Lead serves as a senior leader within the Analytical... ...leadYou ensure compliance and inspection readiness by establishing robust...RegulatoryFull timeLocal area- A biotechnology company in Cambridge, MA is looking for a Senior Director of Biostatistics to lead statistical activities for clinical programs, provide input during regulatory submissions, and mentor junior statisticians. This role demands expertise in statistical analysis...SeniorRegulatory
- ...seeking a seasoned biostatistician to serve as the statistical lead for one or more clinical programs in the U.S. You will provide... ...closely with cross-functional teams to shape development plans and regulatory interactions. You will oversee the statistics and programming...SeniorRegulatory
- Alnylam Pharmaceuticals is looking for a Senior Manager, Medical Writing to join our team in Cambridge, Massachusetts. This role involves... ...over 6 years of medical writing experience, familiarity with regulatory submissions, and excellent project management skills. A...SeniorRegulatoryContract work
- ...an Associate Scientific Director, Synthetic Molecule DS Project Lead to lead cross-functional Drug Substance and PV activities for... ...process development or related, with strong leadership, cGMP knowledge, and broad regulatory submission experience. #J-18808-Ljbffr TakedaSeniorRegulatory
- ...validate client information required for account opening and regulatory review.Complete and coordinate KYC, AML, CIP, beneficial ownership... ...better and enables employees’ growth and success. As a leading global financial services company at the heart of the global financial...SeniorRegulatoryWork experience placementWork at officeWorldwideFlexible hours
$170k - $215k
...speculative investment bubbles and also as a leading climate investor and advocate.GMO is... ....Position Overview:GMO seeks to add a senior attorney to its Legal Team. The Senior Legal... ..., intermediary relationships, and regulatory requirements, with a particular focus on...SeniorRegulatoryFull timeLocal areaWorldwideFlexible hours- Regeneron is seeking a Senior Toxicologist to lead nonclinical development programs with regulatory oversight and cross‑functional collaboration. The role requires deep GLP and regulatory expertise to design, conduct, and report studies in rodent and non‑rodent models...SeniorRegulatory
$212k - $333.19k
...will inspire you and empower you to shine? Join us as a Senior Director, Global Program Lead- Neuroscience in our Cambridge, MA office.At Takeda, we... ...enterprise leadersCommitted to simultaneously driving regulatory approval as well as launch and global patient accessAbility...SeniorRegulatoryMinimum wageTemporary workWork at officeLocal areaRemote work- Regeneron is seeking a Senior Toxicologist to lead nonclinical development programs with guidance from a supervisor, working effectively within... ...safety guidelines, and includes primary authorship of regulatory documentation for submission packages. Strong problem‑solving...SeniorRegulatory
- Regeneron Pharmaceuticals, Inc (USA) is seeking a Senior Toxicologist to lead nonclinical development programs with guidance from their supervisor... ...for designing, conducting, interpreting, and reporting regulatory toxicology studies and related pharmacology work in...SeniorRegulatory
- ...Marsden NHS Foundation Trust in Chelsea, London, is seeking a Senior Research Assistant Practitioner to support the coordination and... ...ability to work with multidisciplinary teams while maintaining regulatory and governance standards. You will screen patients, assist with...SeniorRegulatoryLocal area
- Vicarious Surgical is hiring a Senior Mechanical Engineer to join our team in Waltham,... ...which provides unique opportunities for our regulatory pathway. This is a terrific opportunity... ...of Design for Manufacturing, Design for Inspection and various assembly...SeniorRegulatory
- Alnylam Pharmaceuticals in Cambridge, MA, is seeking a Principal Medical Writer (equivalent to Associate Director) to lead medical writing on multi-disciplinary teams and oversee contract writers on the clinical program. You will develop key clinical documents in accordance...SeniorRegulatoryContract work
- ...Senior Vice President, Global Regulatory Affairs About the Company A clinical-stage biotechnology company... ...planning. This role is pivotal in leading regulatory interactions with global... ...role demands a leader who can ensure inspection readiness and compliance as the...SeniorRegulatory
- Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global Regulatory Leads, Senior Director is responsible for ensuring that the organization gains regulatory approval for new products and product amendments, while maintaining the currency of...SeniorRegulatoryFull timeLocal area
- Agomab Therapeutics is seeking a Senior Director of Medical Writing to lead the regulatory writing function across multiple programs. This strategic role embeds... ...tools, cross-functional collaboration, and an inspections-ready framework to scale as programs advance to Phase...SeniorRegulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Inspection Lead. Be the first to apply!
- senior lead project manager Cambridge, MA
- senior robotics software engineer Cambridge, MA
- senior devops engineer remote Cambridge, MA
- senior sas administrator Cambridge, MA
- senior IT manager Cambridge, MA
- sr project manager Cambridge, MA
- senior windows systems engineer Cambridge, MA
- consultant senior consultant Cambridge, MA
- senior manager data science Cambridge, MA
- senior principal engineer Cambridge, MA
