24 Seven Talent | Pharma Submissions Specialist | new york city, ny

5 days ago


new york city, United States 24 Seven Talent Full time

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


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