Regulatory Affairs Coordinator
2 weeks ago
Regulatory Affairs Coordinator
We invite qualified candidates to address the following inquiries along with their application materials:
1. Proficiency with commercial or central Institutional Review Boards (IRB)
2. Experience in authority documentation
3. Oversight of research projects across multiple locations
Essential Qualifications:
• Bachelor's degree
• Minimum of 3 years in clinical research
• Proficient in drafting research communications to IRB and study sponsors.
• Responsible for submitting continuations and amendments to regulatory authorities.
• Management of regulatory documentation (including laboratory certifications, CVs, IRB compliance correspondence, medical licenses, FDA Forms, Delegation of Authority Forms, Serious Adverse Event submissions, etc.)
• Knowledge of FDA Good Clinical Practice (GCP) and Good Laboratory Practice (GLP), as well as Local Institutional Review Board (IRB) regulatory standards.
Desirable Qualifications:
• At least 1 year of oncology experience
• CCRP certification
COVID-19 Vaccination Requirement: Required - No Exemptions
Company OverviewA.P.R., Inc. (AlphaProTemps) specializes in delivering top-tier professional staffing solutions. Our recruitment services encompass temporary staffing, contract sourcing, professional and technical specialties, vendor-on-site services, and managed service programs.
-
Regulatory Affairs Director
7 days ago
Santa Rosa, California, United States Medtronic Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Director to lead our global regulatory strategies for transcatheter valve technologies at Medtronic. This role involves overseeing a team, collaborating with stakeholders, and ensuring compliance with regulatory requirements.Key Responsibilities:Develop and implement regulatory strategies for...
-
Head of CMC Regulatory Affairs
1 week ago
Santa Clara, California, United States Bayside Solutions Full timeDirector, CMC Regulatory Affairs - Strategic Leadership Opportunity at Bayside Solutions, Inc.Full-Time Role with Direct HireCompensation: Competitive salary packageLocation: Dynamic Redwood City, CA - Hybrid Work SettingPosition Overview:In the role of Director of CMC Regulatory Affairs, you will be instrumental in shaping and executing regulatory...
-
Head of CMC Regulatory Affairs
2 weeks ago
Santa Clara, California, United States Bayside Solutions Full timeChief, CMC Regulatory Affairs - Strategic Leadership Opportunity at Bayside Solutions, Inc.Position Type: Full-Time with Direct HireCompensation: Competitive salary offeredLocation: Hybrid Work Environment in Redwood City, CAPosition Overview:In the role of Chief of CMC Regulatory Affairs, you will be instrumental in formulating and executing regulatory...
-
Head of CMC Regulatory Affairs
1 week ago
Santa Clara, California, United States Bayside Solutions Full timeChief, CMC Regulatory Affairs - Pivotal Opportunity at Bayside Solutions, Inc.Full-Time Employment with Direct HireCompensation: Competitive salaryLocation: Dynamic Redwood City, CA - Hybrid Work EnvironmentPosition Overview:In the role of Chief of CMC Regulatory Affairs, you will be instrumental in formulating and executing regulatory strategies that...
-
Head of CMC Regulatory Affairs
1 week ago
Santa Clara, California, United States Bayside Solutions Full timeChief of CMC Regulatory Affairs - Pivotal Opportunity at Bayside Solutions, Inc.Position Type: Full-Time with Direct HireCompensation: Competitive salary packageLocation: Dynamic Redwood City, CA - Hybrid Work SettingRole Overview:In the capacity of Chief of CMC Regulatory Affairs, you will be instrumental in crafting and executing regulatory frameworks that...
-
Head of CMC Regulatory Affairs
1 week ago
Santa Clara, California, United States Bayside Solutions Full timeDirector, CMC Regulatory Affairs - Strategic Leadership Opportunity at Bayside Solutions, Inc.Full-Time Position with Direct HireCompensation: Competitive salaryLocation: Flexible Hybrid Work EnvironmentPosition Overview:In the role of Director of CMC Regulatory Affairs, you will be instrumental in shaping and executing regulatory frameworks that facilitate...
-
Head of CMC Regulatory Affairs
1 week ago
Santa Clara, California, United States Bayside Solutions Full timeDirector, CMC Regulatory Affairs - Key Leadership Position at Bayside Solutions, Inc.Full-Time Role with Direct Hire OpportunityCompensation: Competitive salary packageLocation: Dynamic Redwood City, CA - Hybrid Work ModelPosition Overview:In the role of Director of CMC Regulatory Affairs, you will be instrumental in shaping and executing regulatory...
-
Regulatory Affairs Director
1 day ago
Santa Clara, California, United States Bayside Solutions Full timeJob Summary:The position is responsible for providing strategic guidance on CMC regulatory matters and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of pipeline compounds/products.Key Responsibilities:Develop and implement CMC regulatory strategies to support the clinical...
-
Lead Quality and Regulatory Affairs Specialist
2 weeks ago
Santa Clara, California, United States Intellectt Inc Full timePosition: Senior Quality/Regulatory Affairs SpecialistCompany: Intellectt IncRole Overview:As a Senior Quality/Regulatory Affairs Specialist, you will play a pivotal role in ensuring compliance and quality within the regulatory affairs sector. Your expertise will be essential in supporting the regulatory affairs team from a quality assurance and compliance...
-
Regulatory Affairs Specialist II
1 week ago
Santa Clarita, California, United States Boston Scientific Full timeAbout Boston Scientific:Job Title: Regulatory Affairs Specialist II – NeuromodulationKey Responsibilities:Support regulatory submission activities for clinical investigations and product distributions globally.Ensure compliance with regulatory requirements worldwide.Key Accountabilities:Prepare submissions for worldwide product approvals.Support clinical...
-
Senior Regulatory Affairs Consultant
2 weeks ago
Santa Clara, California, United States Direct Staffing Inc Full timePosition Overview:We are seeking a highly skilled regulatory professional to join our Companion Diagnostics (CDx) team. The successful candidate will report to the Sr. Director of Regulatory Affairs (CDx) and must possess extensive global regulatory experience in In Vitro Diagnostics (IVD), Medical Devices, or Pharmaceuticals, with a proven track record of...
-
Senior Regulatory Affairs Consultant
2 weeks ago
Santa Clara, California, United States Direct Staffing Inc Full timePosition Overview:We are seeking a highly skilled regulatory professional to join our Companion Diagnostics (CDx) team. The successful candidate will report directly to the Sr. Director of Regulatory Affairs (CDx) and must possess extensive global regulatory experience in In Vitro Diagnostics (IVD), Medical Devices, or Pharmaceuticals. A proven track record...
-
Santa Monica, California, United States Entravision Communications Full timeJob OverviewPosition: Community Relations and Public Affairs CoordinatorLocation: Santa Monica, CA | Employment Type: Full TimeApplication Process: Interested candidates must apply through Entravision's career portal.Role SummaryAs a Community Relations and Public Affairs Coordinator at Entravision Communications Corporation, you will be pivotal in nurturing...
-
Regulatory Affairs Project Manager
2 weeks ago
Santa Clara, California, United States Intellectt Inc Full timePosition: Regulatory Affairs Project ManagerCompany: Intellectt IncLocation: Santa Clara, CAJob Overview:Education: A Bachelor's degree is mandatory; a Master's degree is advantageous.Experience: At least 3 years of relevant experience is essential.Skills: Familiarity with US and/or Canadian regulations concerning product and/or device approval (FDA) is...
-
Regulatory Affairs Senior Specialist
2 weeks ago
Santa Clara, California, United States Abbott Full timeAbout Abbott:Abbott is a prominent global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their journey. Our extensive range of transformative technologies encompasses various healthcare sectors, including diagnostics, medical devices, nutritionals, and branded generic medications. With a workforce of...
-
Regulatory Affairs Specialist II
4 days ago
Santa Clarita, California, United States Boston Scientific Full timeAbout the Role:We are seeking a highly skilled Regulatory Affairs Specialist II to join our team at Boston Scientific. As a key member of our regulatory team, you will play a critical role in supporting the submission of regulatory documents to obtain and maintain approvals for conducting clinical investigations and commercially distributing products...
-
Lead Regulatory Affairs Consultant
2 weeks ago
Santa Clara, California, United States Abbott Laboratories company Full timeAbbott Laboratories is a prominent global healthcare organization dedicated to enhancing the quality of life for individuals at every stage. Our diverse range of transformative technologies encompasses diagnostics, medical devices, nutritionals, and branded generic medications. With a workforce of 114,000 professionals, we serve communities in over 160...
-
Lead Specialist in Regulatory Affairs
2 weeks ago
Santa Clara, California, United States Abbott Full timeLead Specialist in Regulatory AffairsAbbott stands as a prominent figure in the global healthcare sector, dedicated to enhancing the quality of life for individuals at every stage. Our extensive range of transformative technologies encompasses various healthcare domains, featuring top-tier businesses and products in diagnostics, medical devices,...
-
Regulatory Affairs Specialist II
1 day ago
Santa Clarita, California, United States Boston Scientific Full timeAbout the Role:This is a critical position within Boston Scientific, responsible for supporting the regulatory submission activities to obtain and maintain approvals for conducting clinical investigations and for commercially distributing products worldwide.Your Key Responsibilities:Support the preparation of submissions (e.g., PMA, PMA supplements, CE...
-
Regulatory Affairs Specialist II
10 hours ago
Santa Clara, California, United States Abbott Laboratories Full timeAbout Abbott LaboratoriesAbbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people...