Regulatory Quality & Compliance Lead
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals seeks a Senior Manager, Regulatory Sciences Compliance to lead the regulatory sciences compliance framework and provide oversight across Regulatory Strategy, Operations, Labeling, Global Safety Operations, Medical Safety, and Risk Management. Hybrid role, primarily located in Cambridge, MA, USA. You will drive KPIs, manage deviations and CAPAs, and coordinate QA interfaces and inspections while partnering with cross-functional teams to ensure GMP/GDP alignment and #J-18808-Ljbffr Alnylam Pharmaceuticals
- ...Medicine is seeking a Senior Specialist, Quality Systems Management in Cambridge, MA to lead and optimize quality systems, ensure regulatory alignment, and support supplier audits.... ...across functions to strengthen compliance, manage electronic documents, and drive...Regulatory
$150k - $200k
...biopharmaceutical company is seeking a Medical Writing Lead to oversee the creation of clinical... ...writing experience and expertise in regulatory submissions. This hybrid role allows... ...of writing activities, ensuring quality compliance, and process optimization within a collaborative...Regulatory- ...recruiting for an Associate Director/Director, CMC Regulatory in Cambridge, MA. You will lead regulatory CMC strategies for small molecule... ...to RFIs with minimal supervision, driving high-quality submissions and robust compliance. #J-18808-Ljbffr Relay TherapeuticsRegulatory
$150k - $200k
Medical Writing Lead, Global Clinical Operations, Orion Pharma Cambridge, United Kingdom and 3 more (Hybrid)... ...documents across all phases of drug development and global regulatory submissions, ensuring quality and compliance through leadership and collaboration. Medical...RegulatoryWorldwide$51.7 - $76.82 per hour
...making a difference in people’s lives. LEAD MAMMO/RAD TECHNICIAN Job Description... ...in Mammography to assist in providing quality care to our loyal patient base. Key Responsibilities... ...quality assurance checks, ensuring compliance with regulatory standards (MQSA), and identifying...RegulatoryHourly payWork experience placementShift workDay shift$285k - $350k
...Watertown seeks a Vice President, Head of Quality Assurance to oversee strategic quality... ...role requires demonstrated success in leading quality organizations in clinical and... ...of QA experience, including audit and regulatory compliance skills. The anticipated annual salary...Regulatory$17 - $19 per hour
...Range: $17 - $19 /hourPosition SummaryThe Shift Lead is responsible for executing restaurant... ...consistently delivers excellent guest service and food quality while ensuring compliance with policies, procedures, and regulatory requirements.Key Duties/...RegulatoryLocal areaShift workWeekend work$248.5k
...strategic medical guidance and leads the development of... ...Procedures and strives to maintain compliance with them Liaises with outside... ...experts, investigators, and regulatory authorities in oncology, and... ...Operational responsibility for quality and compliance May provide...RegulatoryWork at officeLocal area- eGenesis, a Cambridge-based biotech company, is hiring a Senior Quality Systems Specialist to bolster QA across GMP manufacturing... ...and training programs, and contribute to quality metrics and regulatory compliance in a fast-paced environment. #J-18808-Ljbffr eGenesisRegulatory
- Generate:Biomedicines seeks a Senior Director of GMP Quality to build and maintain fit-for-purpose quality systems and provide independent... ...and contract labs. You will work with Technical Operations, Regulatory Affairs, Clinical Development, and Supply Chain to support...RegulatoryContract work
$34.28 - $47 per hour
...Lead Facilities Maintenance TechnicianJoining us is a chance to... ...bridging Facilities, Manufacturing, Quality, and Engineering to ensure... ...meet production and compliance requirements.The role operates... ...direct impact on product quality, regulatory compliance, and patient...RegulatoryTemporary workFor contractorsLocal areaShift workWeekend work$190k - $225k
...label and consistent with commercial compliance, legal, and regulatory guidelines. Your territory will include... ...both regional and national strategy Lead execution of regional strategic... ...all activities are delivered with high quality and in compliance with regulatory standards...RegulatoryTemporary workWork at officeWork from homeHome officeFlexible hours- ...developing and managing safe, high quality, affordable housing for low-... ...-for-purpose" data warehouse Lead the design, data modeling,... ...quality, stewardship and compliance. • Python - exposure to Python... ...requirements, an appreciation for regulatory context. • Knowledge of...RegulatoryWork at officeWork from homeMonday to FridayFlexible hours2 days per week
$190k - $235k
...interactions are on-label and consistent with commercial compliance, legal, and regulatory guidelines.Your territory will include NM, AZ, CA, NV, CO... ...engagement plans, ensuring all activities are delivered with high quality and in compliance with regulatory standardsSupport...RegulatoryTemporary workWork at officeWork from homeHome officeFlexible hours- ...SummaryThe Cardiac Sonographer Lead is responsible for... ...accreditation applications and ongoing quality assurance projects. They are... ...accreditation applications, compliance activities, and ongoing quality... ...initiatives to maintain regulatory and program standards.Support...RegulatoryTraineeshipWork at office
- Olema Oncology is seeking an Associate Director, Global Regulatory Affairs Compliance, to advance regulatory strategies across its lead and follow‑on programs. Based in Cambridge, MA or San Francisco, CA, you will partner cross‑functionally to ensure compliant submissions...Regulatory
- Katalyst CRO in Cambridge, MA is seeking an experienced CSV Lead to oversee validation activities for GxP computerized systems... ...deep expertise in CSV lifecycle management, FDA and global regulatory compliance, risk assessments, and cross-functional collaboration to ensure...Regulatory
- A leading pharmaceutical company in Cambridge is seeking a Senior Director, Global Regulatory Lead for GI & Inflammation. This role is critical in ensuring compliance and securing regulatory approvals for new products. The ideal candidate will have over 12 years of experience...Regulatory
- Alnylam Pharmaceuticals is seeking an Associate Director of Regulatory Affairs Strategy in Cambridge, Massachusetts. The role involves leading regulatory strategy for CNS programs and facilitating timely submission of regulatory documents to the US. Applicants should have...Regulatory
- ...business processes, ensuring alignment with US GAAP and regulatory benchmarks. You will lead SOX-related work and support the evolution of the... ...Technical Accounting, External Reporting, and Internal Compliance and gain broad exposure to Formlabs’ global financial operations...Regulatory
- ...pharmaceutical company is seeking an Associate Director for Global Regulatory Affairs. This role involves acting as a Subject Matter Expert and managing all assigned programs while ensuring compliance with advertising and promotion regulations. Candidates should have at...RegulatoryRemote work
- ...supports GFP management across campuses. You will coordinate with Program Offices, Supply Chain, Operations, and government personnel to maintain GFP processes, supervise staff, and ensure regulatory alignment with FAR and DFARS guidelines. #J-18808-Ljbffr Job JunctureRegulatoryRelocation
- Sanofi is seeking a Senior Manager of Regulatory Affairs Advertising and Promotion to independently review promotional materials and develop... ...for campaigns. The role includes serving as regulatory lead for product launches and providing input on labeling and lifecycle...Regulatory
- Parabilis Medicines is seeking an Associate Director, Regulatory Affairs to lead regulatory strategy and execution across the product lifecycle in Cambridge, MA. This role focuses on advancing programs through optimized regulatory plans, with emphasis on NDA/BLA submissions...Regulatory
- ...Arts and Sciences in Cambridge, MA is seeking a Manager of Non-Sponsored Funds to lead financial operations for the non-sponsored funds portfolio, ensuring donor terms and regulatory compliance. The role supervises a team and partners with departments, centers, and...Regulatory
$34.28 - $47 per hour
Role Overview Lead Facilities Maintenance Technician supports the... ...maintenance, ensuring compliance with cGMP, FDA and ISO 13485,... ...Participate in audits and maintain regulatory readiness. Vendor &... .... Review contractor work for quality and compliance. Assist in vendor...RegulatoryHourly payTemporary workFor contractorsLocal areaShift workWeekend work- Fagron US is seeking a Quality Site Head for the 503B Outsourcing facility in Canton, MA,... .... You will oversee QA, QC, training, and regulatory inspections, ensuring deviations and CAPAs... ...keep final products fit for use. You will lead a team of about 175 personnel, drive...Regulatory
- ...will work with PIs, RPMs, and central offices to align budgets, compliance, and strategic oversight. In this hybrid role, you will mentor... ...guides, and resolve complex policy questions, balancing regulatory requirements with operational needs across departments. #J-18...Regulatory
- Amylyx Pharmaceuticals is seeking an Associate Director of Medical, Legal and Regulatory (MLR) Review Governance in the Cambridge, MA area. You will chair weekly MLR meetings and own the end-to-end approval workflow for promotional and external-facing materials. The role...Regulatory
- ...Operations to own one or more early-phase clinical programs. You will lead end-to-end program execution from start-up through CSR,... ...clinical scientists, safety, statistics, data management, and regulatory affairs. The role requires a lean, high-ownership mindset with...Regulatory
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