Pharma Submissions Specialist

Job Summary

To support pharmaceutical product submissions, the freelance Pharma Submissions Specialist will manage the submission process remotely, ensuring compliance with regulatory requirements and timely submissions to health authorities.

Key responsibilities

• Collaborate with cross-functional teams to gather necessary documentation for submissions
• Prepare submission packages and conduct quality checks on documents for accuracy and completeness
• 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