CMC Regulatory Affairs Specialist

Job Title: Regulatory Affairs ManagerLanceSoft, Inc. is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to meet business objectives.Responsibilities:Prepare and submit regulatory...

Associate Director, Regulatory AffairsProclinical Staffing is seeking an experienced Associate Director, Regulatory Affairs to join a clinical-stage biopharmaceutical company in the San Francisco Bay Area.Key Responsibilities:Develop and implement regulatory strategies for development programs in rare diseases.Collaborate with cross-functional teams to...

Regulatory Affairs ManagerThe Thor Companies is seeking a highly skilled Regulatory Affairs Manager to lead our regulatory strategy and submission processes for Chemistry, Manufacturing, and Controls (CMC) associated with Abbreviated New Drug Applications (ANDAs) and generic products.Key Responsibilities:Develop and implement regulatory strategies for CMC...

Regulatory Affairs Director OpportunityProclinical Staffing is seeking a seasoned Regulatory Affairs Director to join a clinical-stage biopharmaceutical company in the San Francisco Bay Area.Key Responsibilities:Develop and implement regulatory strategies for development programs in rare diseases.Collaborate with cross-functional teams to ensure timely...

Job SummaryWe are seeking a highly experienced Senior Manager Regulatory Affairs III to join our team at ATR International. The successful candidate will be responsible for leading the preparation of regulatory submissions, developing global CMC regulatory strategies, and maintaining a current awareness of CMC registration requirements in each of the...

Regulatory Affairs SpecialistLocation: Our innovative client is seeking a Regulatory Affairs Specialist to support regulatory submissions and ensure global compliance with regulatory standards. This role is crucial in managing and preparing documentation for product lifecycle management and licensing activities.Key Responsibilities:Prepare and coordinate...

Regulatory Affairs SpecialistArbonne, a global social selling company, is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a purpose-driven company, we are committed to building an inclusive and sustainable economy that works for everyone.The successful candidate will be responsible for ensuring the compliance of nutritional...

Job SummaryWe are seeking a highly skilled Regulatory Affairs and Documentation Specialist to join our team at Synerfac Technical Staffing. The ideal candidate will have 1-3 years of experience in Regulatory Affairs in the medical device space and be knowledgeable with international regulations.Key Responsibilities• Prepares documentation for international...

{"Job Title": "Regulatory Affairs Specialist", "Job Summary": "We are seeking a highly skilled Regulatory Affairs Specialist to support our client\u2019s transition to the EU\u2019s In Vitro Diagnostic Regulation (IVDR).", "Responsibilities": "\u2022 Support the IVDR project by revising technical files and attending weekly meetings to address issues and...

Regulatory Affairs SpecialistWondercide is seeking a highly skilled Regulatory Affairs Specialist to join our innovation team. As a key member of our regulatory compliance team, you will be responsible for managing all regulatory submissions and ensuring accurate, consistent compliance with regulations in packaging and marketing.Key Responsibilities:Develop...

Regulatory Affairs SpecialistW2 ContractSalary Range: $41,600 - $52,000 per yearLocation: South San Francisco, CA - Hybrid RoleJob Summary:As a key member of our Regulatory Affairs team, you will play a critical role in ensuring compliance with FDA regulations and guidelines. You will be responsible for organizing and identifying gaps in Regulatory files and...

Senior Regulatory Affairs SpecialistWe are NeuroVasc Technologies, a company that delivers excellence through innovation with integrity.This role is on-site and reports directly to the CEO. The Senior Regulatory Specialist is responsible for planning, directing, and coordinating global product registrations and leading regulatory submissions planning and...

Senior Regulatory Affairs SpecialistWe are NeuroVasc Technologies, a company that delivers excellence through innovation with integrity.This role is on-site and reports directly to the CEO. The Senior Regulatory Specialist is responsible for planning, directing, and coordinating global product registrations and leading regulatory submissions planning and...

Job SummaryWe are seeking a highly skilled Principal Regulatory Affairs Specialist to join our team at Accordance Search Group.This is a challenging and rewarding role that requires a strong understanding of regulatory requirements and a proven track record of success in ensuring compliance.Key ResponsibilitiesDevelop and implement regulatory strategies to...

Regulatory Affairs Specialist OpportunityJoin our team at Tucker Parker Smith Group (TPS Group) as a Regulatory Affairs Specialist II in Irvine, CA. This 12-month assignment offers a competitive pay rate of $45-$49/hr.Job Responsibilities:Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities by revising technical files, ensuring...

Job SummaryWe are seeking a highly skilled Principal Regulatory Affairs Specialist to join our team at Accordance Search Group.This is a challenging and rewarding role that requires a strong understanding of regulatory requirements and a proven track record of success in ensuring compliance.Key ResponsibilitiesDevelop and implement regulatory strategies to...

Job Overview:GForce Life Sciences is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with local regulations, particularly in the US and Canada.Key Responsibilities:Review and analyze formulas for compliance with local regulations, focusing on US...

Principal Regulatory SpecialistDiscover International is seeking a highly skilled Principal Regulatory Specialist to join our growing team working on novel technology in the Neurological/Spine space. This role is based in the San Francisco Bay Area, offering a unique chance to make a significant impact in the medical device industry.Key...

Job Title: Senior Regulatory Affairs SpecialistLocation: Cypress HCMExperience: Must have experience composing submissions for IVD devicesPosition Overview:The Senior Regulatory Affairs Specialist will coordinate the collection of technical information and prepare regulatory submissions for in vitro diagnostic (IVD) and medical device licenses for various...

{"title": "Regulatory Affairs Manager", "summary": "EPM Scientific is seeking a highly skilled Regulatory Affairs Manager to support the development and submission of regulatory documents for a leading pharmaceutical client. The successful candidate will have extensive experience in regulatory affairs, with a strong understanding of FDA guidelines and...