Regulatory Manager / Senior Regulatory Manager

Regulatory Manager / Senior Regulatory Manager

Join to apply for the Regulatory Manager / Senior Regulatory Manager role at Precision Value & Health .

Job Type : Regular Full-time

Division : Precision for Medicine

Business Unit : Clinical Solutions

Requisition Number : 5415

Precision for Medicine is recruiting a Regulatory Manager / Senior Regulatory Manager to provide regulatory strategy and guidance for clinical trials, agency meetings, orphan designations, pediatric planning, and accelerated procedures. The role involves preparing regulatory submissions, coordinating with authorities and ethics committees, and leading regulatory activities within project teams.

Essential functions include :

• Providing regulatory guidance throughout the clinical development lifecycle
• Preparing and reviewing submissions to regulatory authorities and ethics committees
• Developing regulatory documents to ensure compliance
• Representing Global Regulatory Affairs in project meetings
• Leading and coordinating regulatory teams and activities
• Maintaining project plans and regulatory intelligence tools
• Contributing to regulatory strategy and timeline development
• Staying updated on laws, regulations, and guidelines
• Providing GCP guidance and training

Qualifications : Minimum Required :

Preferred :

Other requirements :

We offer a dynamic environment focused on groundbreaking cancer therapies, valuing employee contributions and fostering innovation.

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