Regulatory Affairs Manager
3 days ago
Brunel GmbH is seeking a highly skilled Regulatory Affairs Manager - Biobanking to join our team. The ideal candidate will have extensive experience in regulatory affairs, biobanking, and compliance management.
About the Role:The successful candidate will be responsible for collaborating with internal teams in locating documentation and reviewing consent related to HBS.
They will assist the Biobank lead and team in linking samples to consent forms, handling HBS during the reconciliation and curation process, and ensuring continuous process improvement.
The manager will review consent forms for use restriction & storage information, manage HBS retrievals electronically, including receipt, tracking, review, and approval of requests from internal requestors.
They will ensure sample manifests are completed to document the HBS transport or receipt, assist the Biobank lead in identifying & managing sample sharing between teams, and work with the Biobanks to optimise processes around Biobank requirements for compliance.
The manager will work with various Biobanks to ensure sample compliance, participate & contribute to team meeting & discussions, support team members in delivering the Departmental goals, and assist in knowledge curation to allow decision making on inventory which may be in-house, or third parties.
They will maintain records for HBS stored until it meets final disposal and follow destruction process when initiated.
Responsibilities:
- Collaborate with internal teams in locating documentation and reviewing consent related to HBS
- Assist the Biobank lead and team in linking samples to consent forms
- Review consent forms for use restriction & storage information
- Manage HBS retrievals electronically
- Ensure sample manifests are completed
- Assist the Biobank lead in identifying & managing sample sharing between teams
- Work with the Biobanks to optimise processes around Biobank requirements for compliance
- Maintain records for HBS stored
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