Regulatory Submissions Manager

Job Title: Regulatory Submissions Manager

Location: Remote

Duration: 12+ months

Start Date: ASAP

Overview

We are seeking a highly skilled and experienced Regulatory Submissions Manager to join our team on a remote contract basis. The ideal candidate will have recent Veeva experience, particularly in the development of submission content plans, and a strong background in regulatory submissions, including INDs, NDAs, and BLAs. This role requires the ability to support specific hours and occasional weekend work.

Key Responsibilities

• Develop and manage submission content plans using Veeva.
• Prepare and oversee regulatory submissions including INDs, NDAs, and BLAs.
• Ensure all submissions comply with applicable regulatory requirements and guidelines.
• Collaborate with cross-functional teams to ensure timely and accurate submissions.
• Maintain up-to-date knowledge of regulatory requirements and industry standards.
• Support the hours of 1pm-9pm EST (4 days a week) and 1 weekend date of 9am-5pm EST.
  
  

Qualifications

• Recent experience with Veeva, specifically in developing submission content plans.
• Minimum of 4 years of experience in regulatory submissions, including INDs, NDAs, and BLAs.
• Excellent understanding of regulatory requirements and guidelines.
• Strong organizational and project management skills.
• Ability to work independently and manage multiple tasks simultaneously.
• Excellent communication and interpersonal skills.
  
  

Hours

• Must be able to support the hours of 1pm-9pm EST (4 days a week).
• Must be available for 1 weekend date of 9am-5pm EST.
  
  

Interested candidates are to submit their resume and a cover letter detailing their qualifications and experience related to this position.