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 critical in ensuring accurate and compliant regulatory documentation for timely submissions to regulatory bodies like the FDA and EMA.He/she will be responsible for:

• 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 for this position include:

• 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.

Precision Medicine Group offers:

• Opportunity to work in a fast-paced, evolving regulatory environment.