Precision Medicine Group is hiring a
Regulatory Manager
Precision Medicine Group
π΅ $113k-$152k
πRemote - United States
Please let Precision Medicine Group know you found this job on JobsCollider. Thanks! π
Summary
Join Precision Medicine Group as Regulatory Manager to provide regulatory development advice and guidance for optimal conduct of clinical trials. The RM coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, maintaining a current knowledge of regulations and guidance documents.
Requirements
- Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
- 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, pediatric 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
Benefits
- Discretionary annual bonus
- Health insurance
- Retirement savings benefits
- Life insurance and disability benefits
- Parental leave
- Paid time off for sick leave and vacation
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Please let Precision Medicine Group know you found this job on JobsCollider. Thanks! π