Regulatory Submissions Manager
Regulatory Submissions Manager
Intellectt Inc
United States
See who Intellectt Inc has hired for this role
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
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.
- 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.
- 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.
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Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Legal -
Industries
Staffing and Recruiting
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