Regulatory Operations Associate

Job Description

Precision Medicine Group is seeking a Regulatory Operations Associate to provide administrative and operational support to the Regulatory Affairs department. This role is crucial for ensuring accurate, compliant, and timely regulatory documentation submissions to bodies like the FDA and EMA. The Regulatory Operations Associate will manage regulatory submissions, organize documentation, and ensure compliance with guidelines.Role involves:

• Uploading and organizing regulatory documents within submission portals.
• Coordinating the redaction of confidential information.
• Preparing and formatting documents for regulatory submissions.
• Supporting the creation of regulatory submission packages.
• Providing publishing and technical support for submission documents.
• Maintaining knowledge of evolving regulations.
• Maintaining tracking logs for submission timelines.

Requirements:

• Bachelor’s degree or equivalent experience.
• Computer literacy (MS Office/ Office 365).
• Fluency in English, both written and verbal.
• 1-2 years’ experience in document management.
• Previous experience in clinical research, regulatory affairs, or a related field (preferred).
• Familiarity with the CTIS system (preferred).
• Understanding of global regulatory requirements (preferred).
• Experience with document management systems and electronic submission formats (preferred).

Role offers:

• Opportunity to work in regulatory affairs.
• Exposure to global regulatory requirements.
• A chance to work with a leading precision medicine group.