Regulatory Affairs Manager: Pl, HU, RS

This is a full-time role for a Regulatory Affairs Manager. The Regulatory Affairs Manager will be responsible for ensuring compliance with regulatory requirements, managing regulatory submissions, and maintaining quality systems. The position will be:

  1. Acting as primary contact point for regulatory matters within Europe 
  2. Ensuring compliance with relevant laws, regulations, and guidelines related to clinical research activities.
  3. Developing and implementing policies and procedures to ensure regulatory compliance.
  4. Providing regulatory guidance and support to project teams, including reviewing study protocols, informed consent forms, and regulatory submissions. 
  5. Managing regulatory submissions via CTIS to regulatory authorities, clinical trial applications, and amendments. 
  6. Communicating with regulatory agencies as needed to obtain approvals and address any regulatory issues that arise.
  7. Keeping abreast of new and changing regulations and guidelines and ensuring that the organization remains compliant.
  8. Providing regulatory training to staff members and ensuring that they are knowledgeable about regulatory requirements. 
  9. Collaborating with internal and external stakeholders, such as sponsors, investigators, and regulatory agencies, to address regulatory concerns and ensure successful study conduct. 
  10. Leading regulatory inspections and audits, and implementing corrective actions as needed. 
  11. Maintaining documentation of regulatory activities and ensuring that all regulatory documents are filed appropriately

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