Global Regulatory Specialist

About the RoleThe Associate Director, Regulatory Affairs will play a crucial part in ensuring that our regulatory activities are carried out efficiently and effectively. As a key member of the team, you will be responsible for supporting the day-to-day regulatory activities of assigned projects with an in-depth knowledge and understanding of the regulatory...

Key ResponsibilitiesProvide regulatory guidance on project teams and key sub-teams at study levelAssess, develop, and implement competitive global regulatory strategies for ivonescimab, identifying potential risks and mitigation steps with proposed strategiesOwn regulatory activities at molecule and study-level, including clinical trial application (CTA) and...

Lead Regulatory Affairs efforts for Orca Bio, a late-stage biotechnology company developing cell therapies.The ideal candidate will have 12+ years of regulatory experience, including 8+ years in leadership within the biotech/pharmaceutical industry or as a seasoned regulator.We offer a competitive salary range of $180,000 - $250,000 based on prior...

The estimated salary for this role is $182,500 per year, based on the job requirements and industry standards. This compensation package includes benefits, bonus, stock options, and other applicable variable compensation.Job DescriptionMain Responsibilities:Provide regulatory guidance to project teams and key sub-teams at study levelAssess, develop, and...

Job SummaryWe are seeking an experienced Regulatory Compliance Operations Specialist to join our team at Linda Werner & Associates. As a key member of our Legal & Compliance Team, you will play a vital role in ensuring the company's compliance and facilitating readiness for key legal and regulatory requirements.The ideal candidate will have 10+ years of...

What We're Looking ForBA/BS degree in the biological or health-related sciences required; graduate-level degree a plusRelevant bio-pharmaceutical industry experience, including a minimum of 5+ years of experience in regulatory affairsKnowledgeable of US FDA and international pharmaceutical guidances, regulations, drug development process, and...

Saxon Global Job Description:Job Title: Lead Hybrid App SpecialistAbout Saxon GlobalWe are a leading financial services company seeking a Lead Hybrid App Specialist to join our Wealth Management team. Estimated Salary Range:$180,000 - $230,000 per year.Job Summary:This full-time position is responsible for leading the development and maintenance of our...

Regulatory Compliance ProfessionaliHealth Labs Inc. is seeking a highly skilled Regulatory Compliance Professional to join our team. In this role, you will be responsible for ensuring the compliance of our medical devices with regulatory frameworks in the US, EU, and China.This is an exciting opportunity to work with a leading provider of cloud-connected...

Genesys Cloud Services empowers organizations to create exceptional customer experiences by leveraging its AI-powered Experience Orchestration platform. This platform enables businesses to deliver personalized, empathetic experiences at scale, driving customer loyalty and workforce engagement.The company is a global leader in the field of customer...

Key ResponsibilitiesAs a Regulatory Affairs Manager at iHealth Labs Inc in Sunnyvale, California, you will be responsible for:Managing regulatory pre- and post-market activities, including preparation and submission of regulatory applications to the US FDA and international authorities.Ensuring compliance with relevant regulations, including ISO 13485, FDA,...

Job SummaryWe are seeking a seasoned Global Corporate Security Director to join our team at Genesys. As a key member of our leadership, you will be responsible for designing, developing, and implementing a comprehensive global security program that protects our people, assets, and operations across all regions.About the RoleDevelop and present business cases...

Key ResponsibilitiesThis Senior Study Lead Specialist will play a pivotal role in ensuring the success of global clinical trials at Summit Therapeutics Sub, Inc. Key responsibilities include:Oversight of study scope, quality, timelines, and budget with internal functional leads, CROs, and vendorsInitiation and maintenance of relationships with key opinion...

Senior Medical Director OpportunityWe are seeking an accomplished physician to serve as a Senior Medical Director to lead our global Phase 3 clinical trials and BLA filings for Summit therapeutics. As a key member of our team, you will be responsible for developing and executing integrated clinical trial programs, including protocol design and medical...

Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at iHealth Labs Inc.The ideal candidate will have a strong understanding of regulatory frameworks in the US, EU, and China, and be able to communicate effectively with regulators to obtain pre-market approval/clearance.Key ResponsibilitiesDevelop and implement...

About the OpportunityWe are seeking a skilled Clinical Trial Manager to join our team at Summit Therapeutics Sub, Inc. As a key member of our clinical operations team, you will be responsible for leading the planning, execution, and monitoring of global clinical trials.Key ResponsibilitiesLead cross-functional teams, including internal stakeholders and...

About the RoleThe Senior Mechanical Commodity Manager will play a critical role in driving the growth and success of Mainspring Energy, Inc.'s supply chain operations. You will be responsible for developing and executing a global sourcing strategy that aligns with the company's business objectives, while ensuring compliance with regulatory requirements and...

Global Science & Technology, Inc. (GST) is a leading provider of scientific support services to the National Oceanic and Atmospheric Administration (NOAA). As a Science Program Support Specialist, you will play a critical role in assisting our client with various tasks, including budget analysis, liaison work between NOAA Satellite Service offices,...

Job OverviewAerotek is seeking a highly skilled Environmental Health and Safety Specialist to join our team. This role will lead the integration of solutions that address multiple regulatory requirements and certifying agencies, ensuring compliance with rules affecting safety, security, hazardous waste, medical equipment, fire/life safety, and utilities.Key...

Job SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team at iHealth Labs Inc. in Sunnyvale, California.This role will be responsible for overseeing the development and implementation of regulatory strategies for medical devices, ensuring compliance with ISO 13485, FDA, and MDR/IVDR regulations.The ideal candidate will have a...

About iHealth Labs Inc.iHealth Labs Inc. is a leading provider of cloud-connected medical devices, personal health care devices, and home-based tests. Our mission is to revolutionize the healthcare industry by making quality health management accessible and affordable for all.We are committed to empowering people to live healthier lives through innovative...