Regulatory Manager – Senior Regulatory Manager, Clinical Trials

Job not on LinkedIn

November 12

Apply Now

Receive Emails with Similar Jobs

Precision Medicine Group

WebsiteLinkedInAll Job Openings

Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

1001 - 5000 employees

Founded 2012

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $35.2M Venture Round on 2021-03

📋 Description

• Provides regulatory guidance throughout the clinical development life cycle • Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications. • Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards • Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers • Works within a project team, and where necessary, leads project for the region or globally • Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated. • Assist in development of Regulatory Affairs Specialists and other operational area staff, as required • Provide input, as required, into regulatory strategy and timeline development for new study opportunities • Assists in establishing company standards to ensure the highest quality of submitted information • Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions. • Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval • Provides ICH GCP guidance, advice and training to internal and external clients • Serve as representative of Global Regulatory Affairs at business development meetings

🎯 Requirements

• Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline • 5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level • Computer literacy (MS Office/ Office 365) • Fluent in English

🏖️ Benefits

• Competitive salary • Flexible working hours • Professional development opportunities • Remote work options