Global Submissions Management Manager
A vacancy has arisen for a Manager to oversee Global Submissions, you will support Global Systems and process development on a basic level and process redesign.
- Establish and organise electronic collaboration environments structures for storage and retrieved system, and maintenance of regulatory documents
- Participate in project team meetings for the publishing of regulatory documents and submissions
- Responsible for updating and maintaining the Global Calendar Project Status
- Coordinate submission team discussion/meetings (Preparation, Kick off, module and submodule meetings)
- Prepares team for Submission Plan Endorsement Meeting (Related to High-Level Projects - RA President & Head of RegOps) Currently EU/US specific
- Ensuring adequate resourcing for submissions activities to ensure timelines are met, including managing internal and external resources, coordination with line management to ensure resource collaboration across sites.
- Effectively communicates with Regulatory Sub Team (submission progress & issues)
- Initiate and conduct lessons learned sessions accordingly (Supported by Senior Managers if required)
- Analyses submission status reports for consistency and accuracy of information
- Analyses data acquiring and present key metrics
- Works with multiple resources within and across groups to meet project deliverables concerning the global regulatory requirements
Skills and Requirements
- Excellent communication skills required to interact effectively with regulatory affairs members and regulatory colleagues in gathering the necessary information required for submissions, and to proactively address sensitive issues with diplomacy and tact.
- Applies good judgement and demonstrates initiative to resolve issues.
- Advance understanding of Submission Project Management tools and techniques.
- Identifies problem-solving resolution and facilitates team(s) to identify risks and propose solutions concerning regulatory issues
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.