Regulatory Submission Project Management - Contract - New York
À±½·ÊÓƵ is seeking a Regulatory Submission Project Management professional to support the Regulatory Submission Management (Reg SM) group. This position offers an opportunity to work in a dynamic environment, ensuring compliance with regulatory requirements and supporting critical submission processes.
Primary Responsibilities:
The successful candidate will assist with routine regulatory submissions, track deadlines for various regulatory obligations, and contribute to major submissions such as INDs, CTAs, BLAs, supplements, MAAs, and variations.
Skills & Requirements:
- Strong knowledge of applicable regulatory agency regulations, guidelines, and specifications (e.g., FDA, EMA, ICH).
- Familiarity with eCTD and experience in submission processes and systems.
- Ability to work under firm deadlines and adapt quickly to changing priorities.
- Expertise in document management and proficiency with MS Office applications, Adobe Acrobat, and electronic document management systems (eDMS).
- Bachelor's degree in a relevant field.
The Regulatory Submission Project Management's responsibilities will be:
- Schedule and manage routine regulatory submissions, including IND safety reports, clinical site documentation updates, 1572s, lot releases, and promotional materials.
- Provide support for monitoring and tracking the performance of submission processes for clinical site documentation and Form FDA 1572.
- Coordinate publications and literature references for submissions across all programs.
- Track submission deliverables for routine submissions and assist in tracking deliverables for larger submissions.
- Ensure the overall completeness of scheduled submissions and coordinate with Regulatory Operations on submission timing and document status.
Compensation:
If you are having difficulty in applying or if you have any questions, please contact Alex Bill at a.bill@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
À±½·ÊÓƵ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. À±½·ÊÓƵ is acting as an Employment Agency in relation to this vacancy.
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