Regulatory Affairs Specialist
Yesterday
Description
• Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. • Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies. • Develop stakeholder tools, process/document regulatory risk assessments, and provide support, expertise and represent the unit with other functional units, sponsors, researchers and/or regulatory authorities. • Ensure high quality, timely service delivery processes are maintained in accordance with corporate, industry and regulatory standards and guidelines. • May be required to coach peers and/or provide input for staff performance reviews.
Requirements
• Applicants should have a minimum of an undergraduate degree and 4-6 years of relevant experience in Clinical Research/Regulatory Affairs. • The successful candidate will possess strong knowledge of EMA regulations.
Benefits
• Accommodations for job applicants with disabilities are available upon request.
Apply NowSimilar Jobs
December 7
Ensure compliance with ISMS and security standards in digital business solutions development. Lead ISMS program and cross-functional team collaboration for regulatory adherence.
November 30
Lead vulnerability management at interface.ai, ensuring compliance and security in AWS environments.
November 27
Looking for an ESG Compliance and Reporting Specialist focusing on European standards for software solutions.
November 18
Oversee trade surveillance and regulatory compliance for a crypto-related financial institution.