Role Overview: We are currently seeking a highly skilled and detail-oriented Pharma Submissions Specialist to join our team on a temporary basis. As a Submission Specialist, you will be responsible for managing the submission process for pharmaceutical products, ensuring compliance with regulatory requirements and timely submissions to health authorities.

Pharma Submissions Specialist Responsibilities:

• Collaborate with cross-functional teams, including Regulatory Affairs, Clinical Operations, Quality Assurance, and Medical Writing to gather necessary documentation for submissions.
• Ensure all submitted documents meet regulatory standards and guidelines.
• Prepare submission packages according to specific health authority requirements.
• Conduct quality checks on submission documents for accuracy and completeness.
• Maintain up-to-date knowledge of relevant regulations and guidelines related to drug submissions.
• Keep track of submission timelines and ensure timely delivery of submissions.
• Assist in resolving any issues or queries related to submissions from health authorities.

Pharma Submissions Specialist Qualifications:

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