Accept regulatory assignments each week as assigned by the Regulatory Affairs Manager. The Regulatory Affairs Analyst will support and obtain human subjects and safety committee approvals for oncology clinical trials supported by the HDFCCC CRSO. The analyst works independently, under the direction ...
Responsible for supporting teams & efforts around major filing activities & Regulatory Health Authority (RHA) interactions & meetings, attending & providing regulatory support to other departments, project teams & committees. Assist Regulatory Staff by identifying & gathering...
VP, QC/Regulatory and help provide leadership and management direction for all regulatory compliance activities on a domestic and international level across all brands. Manager, Regulatory will work closely with cross-functional teams to help determine regulatory strategies and ensure compliance wit...
HIM Director-Regulatory Affairs Manager. Experience conducting training for quality assurance and/or regulatory affairs. Certification in regulatory affairs, quality assurance or clinical research; ASQ (American Society for Quality) Certification is preferred. Establish and operationalize policies, ...
They are seeking a Vice President of Regulatory Affairs to oversee all regulatory activities including serving as the primary contact with FDA and other regulatory agencies. Build, lead, and manage the Regulatory Affairs function to ensure adherence to regulatory standards and requirements for the c...
Serve as the PDM regulatory representative on project teams, provide CMC regulatory support for the clinical development of the investigational product(s), and ensure applicable regulatory requirements are appropriately met. Director, CMC Regulatory Affairs. The position is responsible for providing...
HIM Director-Regulatory Affairs Manager. Experience conducting training for quality assurance and/or regulatory affairs. Certification in regulatory affairs, quality assurance or clinical research; ASQ (American Society for Quality) Certification is preferred. Establish and operationalize policies, ...
A growing immune-oncology company is seeking a Senior/Executive Director of Regulatory Affairs to join the team in executing regulatory strategies and supporting the development of their product pipeline with an emphasis on early stage development. Lead regulatory strategy, provide regulatory guidan...
Lead the Regulatory Team that may include external consultants or other Clinical or CMC Regulatory Affairs personnel, Regulatory Medical Writing, Quality Assurance and Pharmacovigilance and Drug Safety functions. In this role, the VP of Regulatory Affairs will draw on extensive experience and strong...
Confer with other Regulatory Affairs subject matter experts regarding regulatory requirements of new product designs and/or changes to existing designs. Senior Regulatory Affairs Specialist-Remote Based-West Coast. Global Regulatory Affairs Director. This Senior Regulatory Affairs Specialist will ha...
Our Regulatory Affairs Lead will develop and own our end-to-end regulatory strategy. Full Time] Governmental and Regulatory Affairs Lead at Alga Biosciences (United States) | BEAMSTART Jobs. Governmental and Regulatory Affairs Lead. This team member will be responsible for coordinating across our sc...
Five to eight or more years of experience in Regulatory Affairs in the pharmaceutical industry for the Senior Manager level; Eight to ten or more years of experience in Regulatory Affairs in the pharmaceutical industry for the Associate Director level. Represent Regulatory Affairs on cross-functiona...
HIM Director-Regulatory Affairs Manager. Experience conducting training for quality assurance and/or regulatory affairs. Certification in regulatory affairs, quality assurance or clinical research; ASQ (American Society for Quality) Certification is preferred. Establish and operationalize policies, ...
Provides guidance to the teams on the regulatory requirements supporting CDx submissions to US FDA and other global health authorities and ensuring that all regulatory submissions are planned, communicated, and executed per regulatory and business requirements. Participates in internal and joint pro...
Closely monitor, analyse, develop regulatory priorities and coordinate positions and strategies for regulatory and market affairs in MISO and other priority markets. Communicate regularly and effectively in a cross-functional matrix with development, origination, fundamentals, finance, and political...
Regulatory expert support IVDR teams, implements regulatory strategies for IVDR activities; provides regulatory leadership; collaborates with the regulatory staff from other business units, companies, government agencies as needed to develop harmonized policies, procedures and work instructions for ...
Manage portfolio timelines in collaboration with Regulatory Operations and Regulatory Affairs staff to effectively enable a robust regulatory submissions calendar. Review clinical site regulatory documents to provide Regulatory approval to ship investigational product. Assist Project Team Regulatory...
As a Staff Regulatory Affairs Specialist with a fast growing, AI software and wearable hardware medical device company, you will be responsible for working with cross functional teams to assess and develop global product registration strategies, help guide project teams from preparation to submissio...
Leor Weinberger, director of the Gladstone-UCSF Center for Cell and Viral Circuitry, seeks a highly motivated Regulatory / Clinical Affairs Specialist to manage regulatory affairs, author and assemble IND applications, and help manage FIH studies on new antiviral gene therapeutic candidates. The pos...
Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical devices. Senior Regulatory Affairs Specialist. Prepares robust regulatory applications/submissions...
Identifies growth and areas of opportunity to enhance Regulatory Affairs and AHS initiatives. Assists in all accreditation and regulatory activities, including surveys, survey preparation and readiness assessments. Finalizes corrective action responses to The Joint Commission and other regulatory ag...
KEY RESPONSIBILITIES As local regulatory lead, represent Regulatory Affairs (RA) in assigned project meetings and provide regulatory guidance as appropriate, and for preparation of regulatory documents. POSITION SUMMARY The Director of Global Regulatory Affairs will serve as a pivotal member ...
Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market. Collaborate with various regulatory consultants, clinical advisory board members, and board members to maintain regulatory knowledge...
The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned oncology products. Would you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company ...
In collaboration with Regulatory Affairs functional management, coordinate the provision of resources from the various Regulatory functions in support of clinical studies. Innova Solutions is immediately hiring for an Associate Director, Regulatory Affairs. Associate Director, Regulatory Affairs , y...