Regulatory Submission Specialist

Job Summary

To support the Diagnostics Regulatory Affairs team, the part-time remote Regulatory Submission Publishing Specialist will manage and facilitate the preparation, submission, and publishing process of regulatory submissions for registration purposes, primarily in the US and EU, working 24-32 hours per week.

Key Responsibilities

• Coordinate the submission and publishing process for regulatory registrations in the US and EU markets
• Prepare submissions according to external health authority guidelines and internal standard practices
• Liaise with project leads and regulatory bodies to gather necessary documents and ensure smooth submission processes

Required Qualifications

• BA in Life Sciences, Regulatory Science, Quality, or related field
• Proven experience in preparing compliant regulatory submissions in the diagnostics or pharmaceutical sector
• Proficiency with industry-standard publishing and submission software and tools
• Familiarity with regulatory guidelines such as FDA, EMA, ICH, GxP, and publication ethics
• Ability to manage multiple projects and meet deadlines in a fast-paced environment