Precision Medicine Group is hiring a
Regulatory Manager / Senior Regulatory Manager
Precision Medicine Group
π΅ ~$171k-$235k
πRemote - Hungary
Please let Precision Medicine Group know you found this job on JobsCollider. Thanks! π
Summary
Join Precision for Medicine (CRO) as a Regulatory Manager to provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures.
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
Responsibilities
- 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
Preferred Qualifications
- Graduate, postgraduate
- Possesses basic understanding of financial management
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