Regulatory Affairs Specialist

hace 2 semanas

Alcobendas, Madrid, España Precision Medicine Group A tiempo completo
Regulatory Manager Job Description

Precision for Medicine is seeking a highly skilled Regulatory Manager to provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, and submissions to Regulatory Authorities and/or Ethics Committees.

Key Responsibilities:
  • Develop and implement regulatory strategies to ensure compliance with applicable regulations and guidelines.
  • Provide regulatory guidance throughout the clinical development life cycle, including CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications.
  • Compile, coordinate, and review applications to Regulatory Authorities, including CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications.
  • Develop and/or review 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.
  • Work within a project team, and where necessary, lead 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.
  • Participate in maintaining and executing on the corporate quality initiatives across business units within clinical solutions.
  • Keep 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.
Qualifications:
  • Bachelor's 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.

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