Regulatory Submission Project Management - Contract - New York
Proclinical 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.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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