Description
Regulatory Affairs Manager - 9 month contractMy client an orphan drug company based in Basel, Switzerland is currently searching for a Regulatory Affairs Manager to be responsible for the operational and strategic activities in drug development, centralised procedure for pre and post-marketing phases.
The role reports to the Head Drug Regulatory Affairs and will collaborate closely with
other functions such as Clinical Research, Pharmacovigilance, Biostatistics and Commercial operations.
Responsibilities:
- Clinical Trial Authorisation applications
- Preparation and submission for regulatory approval of clinical trial authorisation applications
- Maintenance of existing clinical trial authorisations
- Input in decision process regarding clinical trials conduct and strategy
- Supervises regulatory CRO counterpart as applicable
- Coordination of clinical study report activities as required
- Pre-authorisation regulatory activities
- Preparation and submission of meetings with Health authorities
- Coordination of responses to Health Authorities
- Support with regulatory strategy and communication
- Support with registration activities
- Post-authorisation regulatory activities
- Preparation and submission of variations through centralised procedure
- Labelling activities
- Review of promotional materials and liaising with Marketing/ Medical Affairs
- Regulatory Intelligence
- Preparation and maintenance of a central source of Regulatory Intelligence information, including but not limited to therapeutic area and general EU and US regulatory guidance information
- Preparation of Orphan Drug annual reports for EU and US
- Coordination of periodic reports or other update to regulatory documents as required, e.g PSUR, RMP, IB, CCDS.
- Document management
- Filing and archiving the regulatory documents according to SOPs
- Maintenance of electronic filing systems
- Maintenance of internal regulatory database
Requirements:
- Mandatory previous experience in a pharmaceutical company or a CRO
- Minimum Bachelor degree in life science
- Minimum 3-5 years of experience in a similar role, responsible for EU regulatory affairs
- Demonstrated experience in regulatory activities in centralised procedure
- Experience in clinical trial applications
- Previous experience in orphan drugs will be highly appreciated
- Knowledge of EU and FDA regulatory affairs guidelines & regulations
- Previous experience in operating within complex matrix organisations
- Fluency in English, both written and oral
Keywords: post marketing authorisation,centralised procedures, regulatory affairs, FDA, EMA, english
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.