Pharma Submissions Specialist

Job Summary

To support the submission process for pharmaceutical products, the freelance Pharma Submissions Specialist will manage submissions to health authorities, ensuring compliance with regulatory requirements while working remotely on a temporary basis.

Key responsibilities

• Collaborate with cross-functional teams to gather necessary documentation for submissions
• Prepare submission packages and conduct quality checks for accuracy and compliance with regulatory standards
• Maintain knowledge of relevant regulations and track submission timelines for timely delivery

Required qualifications

• Proven experience as a Submissions Specialist within the pharmaceutical industry
• In-depth knowledge of FDA regulations related to drug development and submissions
• Experience with FUSE
• Strong organizational skills and attention to detail
• Ability to work effectively in cross-functional teams under tight deadlines