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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Legal
Industries
Staffing and Recruiting
Referrals increase your chances of interviewing at Intellectt Inc by 2x