Regulatory Affairs Associate I

Regulatory Affairs Associate I External ID # Fremont, CA - ON SITE 22 month W2 contract (with potential to extend or transition to perm) Pay rate: $30-35/hour - Depending on Education and Experience Summary: Shift: 1st Shift: Mon-Fri, 8:00AM-5:00PM Responsibilities:Assist in preparing responses to global information requests and related maintenance...

Regulatory Affairs AssociateLocation: Fremont, CAOur innovative client is seeking a Regulatory Affairs Associate 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...

Regulatory Affairs Associate IYoh is seeking a highly motivated and detail-oriented Regulatory Affairs Associate I to join our team. As a Regulatory Affairs Associate I, you will assist in preparing responses to global information requests and related maintenance documentation, determine regulatory strategies for manufacturing changes and regulatory...

Regulatory Affairs AssociateLocation: Fremont, CAOur innovative client is seeking a Regulatory Affairs Associate 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...

Job Title: Regulatory Affairs Associate IDuration: 08 Months Contract (Possible Extension)We are seeking a highly motivated and detail-oriented Regulatory Affairs Associate I to join our team at US Tech Solutions. As a key member of our regulatory team, you will play a critical role in ensuring compliance with global regulations and standards.Assist in...

Regulatory Affairs Associate I Job DescriptionWe are seeking a highly skilled Regulatory Affairs Associate I to join our team at Yoh. As a key member of our regulatory team, you will be responsible for assisting in preparing responses to global information requests and related maintenance documentation.Key Responsibilities:Assist in preparing responses to...

Top 3-5 skills, experience or education required1. Ability to critically and effectively review detailed information to support a labelling revision including all applicable regulations.3. Detail-oriented with the ability to proofread and check documents for accuracy and consistency.Purpose Statement:The Regulatory Affairs Specialist supports the development...

Regulatory Affairs AssociateJob SummaryMeet is seeking a highly skilled Regulatory Affairs Associate 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 ResponsibilitiesPrepare and coordinate...

Duration: 08 Months Contract (Possible Extension)Description:Assist in preparing responses to global information requests and related maintenance documentation (amendments, supplements, annual reports, safety reports, etc.) within a defined schedule. Help determine regulatory strategies for manufacturing changes and regulatory activities. Aid in preparing...

Immediate opportunity for a REMOTE Regulatory Affairs Senior Associate within the Regulatory Information Management & Systems (RIMS) team with one of the world's leading biotechnnology companies located in Thousand Oaks, CA.Schedule/Shift: 1st shift, Mon.-Fri., EST time zone preferredPosition type: 1 year contrat (through November 2025); extension...

Job Summary:Yoh is seeking a highly skilled Regulatory Affairs/Quality Associate to join our team. As a key member of our regulatory team, you will play a critical role in ensuring compliance with global regulations and cGMP requirements.Key Responsibilities:Help determine regulatory strategies for manufacturing changes and regulatory activities.Coordinate...

Sr Associate, Regulatory Affairs Sr Associate, Regulatory Affairs sought by Karyopharm Therapeutics, Inc., a commercial-stage pharma co in Newton, MA: Manage reg submissions, publish and prep submission docs, proficiency with eCTD tools and processes, track regulatory filings, etc. Telecommuting acc

Job Title: Regulatory Affairs SpecialistAt eTeam, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for assisting in preparing responses to global information requests and related maintenance documentation. Your duties will include determining regulatory strategies...

Job Title: Associate Director/Director, Regulatory AffairsScribe Therapeutics is a molecular engineering company focused on creating best-in-class in vivo therapies that permanently treat the underlying cause of disease. Our team is passionate about developing custom engineered enzymes and delivery modalities as part of a proprietary, evergreen CRISPR by...

We are NeuroVasc Technologies! We deliver excellence through innovation with integrity.This On-site role reports directly to the CEO. The Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and execution; collaborate with Product Regulatory and Regional Regulatory...

Job DescriptionScribe Therapeutics is a molecular engineering company focused on creating innovative in vivo therapies that address the root causes of diseases. Our team of experts, including CRISPR inventors and leading molecular engineers, is dedicated to developing custom engineered enzymes and delivery modalities as part of our proprietary CRISPR by...

Regulatory Affairs Specialist II Location: Irvine, CA (Hybrid 3 days on site)12 month AssignmentPay Rate: $45-$49/hr.On behalf of our client a medical device client, we are seeking a Regulatory Affair’s specialist that will support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact the company’s products currently CE...

This clinical-stage biotech company is developing small molecule therapeutics for the treatment of devastating cancers and immune disorders. They are seeking a Vice President of Regulatory Affairs to develop and lead global regulatory strategies for their portfolio of programs and serve as the primary contact with health authorities. You will provide crucial...

Job Title: Director Regulatory AffairsLocation: Weston, FL (near Miami and Fort Lauderdale, Florida (FL))Function: Regulatory AffairsReports to: Chief Regulatory Affairs Officer Job Summary:The Director of Regulatory Affairs will be responsible for the preparation and management of ANDA submission and oversee and manage all ANDA regulatory activities pre-...

Position Overview: The Senior Regulatory Affairs Specialist creates, evaluates, and completes regulatory tasks related to the following: worldwide product registration submissions, facility registrations, technical files, FDA submissions, special projects, and strategy to drive market growth worldwide. This individual is responsible for obtaining global...