Senior Manager, Regulatory Document Management - REMOTE
Job description
Proclinical is seeking a remote Senior Manager of Regulatory Document Management with an international biotech company. As a document management lead, you will oversee the technical quality of regulatory documents ensure their submission readiness, and drive the document compilation/adherence process.
Job Responsibilities:
- Responsible for providing submission management and Publishing for BLAs, INDs, and CTAs applications.
- Responsible for interfacing with project managers, regulatory leaders, and/or content authors to discuss planned submission preparation.
- Identifies regulatory risks and emerging issues and proactively develops mitigations and solutions.
- Ensures that all regulatory content and information is appropriately tracked, archived, searchable, and accessible via Document Management System.
- Responsible for the creation, assembly, and publishing of routine eCTD submissions for IND and BLA applications.
- Efficient at producing high-quality graphics for inclusion in protocols, CSRs, IBs, etc.
- Adherence to required submission timelines, health authority publishing specifications, and internal working practices.
Skills and Requirements:
- 4+ years in pharma/biotech space
- Good understanding of regulatory requirements and drug development processes, GCP/GXP, and guidelines associated with regulatory documents.
If you are having difficulty in applying or if you have any questions, please contact Trajan Susa-Coelho at (+1) 858-727-2330 or t.susa-coelho@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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