Pharmacovigilance Compliance & Training Manager
Scorpion Therapeutics
Scorpion Therapeutics is seeking a Pharmacovigilance/Quality Compliance professional to support the global PV QMS and regulatory alignment in a fast-paced biotech environment. You will author and maintain PV procedures, develop role-based training, and help drive metrics and improvements across the PV system. This role requires collaboration across functions and vendors to ensure compliance with FDA, EMA, ICH guidelines. #J-18808-Ljbffr Scorpion Therapeutics
$153k - $178k
...Summary:Vaxcyte is seeking a hands-on and detail-oriented Lab Compliance Manager to join our Global Analytical organization in San Carlos, CA... ...testing.Coordinate and deliver role-based laboratory training in alignment with QA-established training requirements, maintaining...SuggestedWork experience placement$129.5k - $175k
WHAT IS BOX?Box (NYSE:BOX) is the leader in Intelligent Content Management. Our platform enables organizations to fuel collaboration,... ...WHY BOX NEEDS YOU We are looking for an experienced and driven Compliance manager who is looking to put their auditing experience, technical...SuggestedLive inWork at officeShift work3 days per week$244k - $305k
...pathway.The Opportunity:The Sr. Director, US Compliance will serve as the lead compliance... ...delivery of engaging, risk-based compliance training to NSCLC business teams, ensuring... ...and other governance controls.Develop, manage, and conduct monitoring and auditing activities...SuggestedFull timeLocal areaShift work$183k - $194k
...global regulatory CMC strategies for investigational products and leads the preparation and filing of regulatory CMC submissions. Manages interactions with Health Authorities for CMC topics. Provides regulatory CMC guidance to various cross-functional teams and ensures...SuggestedRelocationRelocation package$246.04k - $295.8k
...experiences for everyone.Roblox is looking for a Senior Payments Compliance Manager to lead the design and enforcement of our global Know Your... ...of job-related factors such as professional background, training, work experience, location, business needs and market demand...SuggestedFull timeWork experience placementH1bWork at officeLocal areaVisa sponsorshipMonday to Friday$97.6k - $188.4k
...engineers can focus on their core work. We are looking for a Training Manager to own learning and enablement for AIX end to end. Today our... ..., university hires accelerating through Aspire, and full compliance with Microsoft's required training. You will influence far more...Ongoing contractWork at officeLocal area- ...regulatory CMC experience and a successful track record in preparing BLAs. This role involves close collaboration with internal teams and regulatory authorities to ensure compliance and optimize submission processes. Competitive salary based on experience. #J-18808-Ljbffr...
$250k - $300k
...approval regulatory operations and lifecycle management, while also maintaining regulatory... ...marketing commitments.Provide ongoing compliance support for the commercialized product... ...closely with Clinical, CMC, Quality, Pharmacovigilance, and Commercial teams to execute...Full timeLocal areaImmediate startRemote work$201k - $251k
...filings for late-stage oncology programs at RevMed. They will manage end-to-end execution of the dossier, ensuring cross-functional... ...skills, experience, market dynamics, and relevant education or training.Please note that base pay salary range is one part of the overall...Full timeWork experience placementLocal area$244k - $305k
...from IND-enabling activities through registration and lifecycle management. This leader will shape innovative and efficient regulatory... ...skills, experience, market dynamics, and relevant education or training.Please note that base pay salary range is one part of the overall...Full timeLocal area- ...impacting issues; develop strategies and communicate to teams/management. Ensure regulatory strategy alignment with clinical development... ...and investor communications with regulatory insights. Ensure compliance with applicable laws and regulations for product development and...
- ...regulatory standards for patient and healthcare professional interactions. You will oversee regulatory review cycles, tracking, and compliance across geographies, guiding MLR processes and labeling strategies while supporting enterprise sales and deployments with clinical...
- ...innovation in cell therapy, including gene‑edited cell therapy, which may be a promising option for patients with cancer. Overview The Manager, Regulatory Affairs, represents Regulatory Affairs on cross‑functional teams, working closely with other team members to support...Work at officeRemote work
$130k - $179k
...patients. For more information, please visit our website at . Manager, Regulatory Affairs Adicet Bio is seeking a highly motivated Manager... ..., DSURs, Investigator Brochures, to ensure GxP and regulatory compliance. Assist in maintenance and tracking of company databases,...Full timeTemporary workWork at officeFlexible hours3 days per week- Rezolute is seeking a Sr Director of Regulatory Affairs to lead regulatory strategy and execution for late-stage biologics programs. You will drive FDA interactions, strategy development, and submissions to support HI biology programs and tumor-related indications. This...
- ...to lead strategic medical writing for NDA submissions and regulatory documents in a fast-paced, small company environment. You will manage a team and external vendors, define content standards, and ensure high-quality deliverables across multiple therapeutic areas,...
$106.2k - $132.7k
DescriptionThe Training Supervisor, Quality Assurance is responsible for supporting training... ...metrics of training program and run management reportsFacilitate face-to-face training... ...privacy, General Policies andProcedure Compliance training and security training as soon...Work experience placementWork at officeImmediate startWorldwide$166k - $195k
...across communications and decision making.Summary:The Sr. Project Manager, Regulatory CMC will serve as a key contributor to the company’... ...degree desired.PMP Certification and/or Project Management training desired.8+ years of experience in the pharmaceutical or biotechnology...3 days per week$99.45k - $140k
BUSINESS TITLE: IRB Coordination Manager (Research Compliance Manager 1) WORK SCHEDULE:This position is a hybrid work role - a combination of onsite work and telecommuting - based on business and operational need.BUDGETED SALARY: $99,448 - $140,000SCHOOL/UNIT DESCRIPTION...Casual workWork at officeLocal areaRemote workWeekend workAfternoon shift$186k - $233k
...The Opportunity:The Associate Director, Compliance - Field Commercialization, with support... ...with business objectives.Field Training & CommunicationOwn the strategy, design... ...leadership, communication, and stakeholder management skills.Preferred Skills:Certified Compliance...Full timeLocal area$180k - $210.5k
...leads the preparation and filing of regulatory CMC submissions. Manages interactions with Health Authorities for CMC topics. Provides... ...regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations...$164k - $205k
...validation (CSV) background to play a critical role as Senior Manager, IS Quality and Compliance within the Information Sciences (IS) organization. This... ...experience, market dynamics, and relevant education or training.Please note that base pay salary range is one part of...Full timeLocal area- ...enabling through Phase 1/2) with pragmatic, stage-appropriate CMC approaches. ~ Proven ability to lead cross-functional workstreams, manage multiple priorities, and deliver high-quality outputs under tight timelines. ~ Strong interest in longevity and aging biology,...
- Retro is seeking an experienced Regulatory professional to own the strategy and operations for CMC regulatory work across our aging biology programs. This onsite role in Redwood City reports to the Regulatory Affairs leader and will build out global CMC capabilities for...
- Revolution Medicines is seeking a Sr. Director, US Compliance to lead the strategic compliance efforts for planned US NSCLC commercialization. Based in Redwood City, CA, this hybrid role partners with Commercial, Medical Affairs, Market Access and other functions to embed...
- ...address them and communicate to the project teams and Company management. Ensure alignment of regulatory strategy with clinical development... ...and investor communications with regulatory insights. Ensure compliance with applicable laws and regulations related to our product...Local area
- ...to all appropriate departments to assure compliance with applicable regulations. Remains... ...regulatory strategy and submissions. Actively trains/mentors junior staff; provides broader... ...or therapeutic protein. 5+ years of management experience preferred. The salary is competitive...
- ...delta T cell therapies for autoimmune diseases and cancer. The Manager, Regulatory Affairs will lead global CMC regulatory strategy... ...collaborate with regulatory, clinical, and manufacturing teams to ensure GxP compliance across programs. #J-18808-Ljbffr Adicet Bio, IncWork at office3 days per week
$137k - $185.5k
Overview We are seeking an experienced Senior Manager to monitor and manage Payment Network Rule changes—with deep, hands‑on expertise... ...to the development and oversight of programs that ensure compliance with Payment Network Rules, Sponsor Bank, and regulatory requirements...- ...a clinical stage biotechnology company developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. The Manager, Regulatory Affairs will lead global CMC regulatory strategies and submissions in early to late-stage development, supporting additional...
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