Regulatory Manager (Healthcare - 2 year FTC - Renewable)

Contract Period : 2 year Fixed Term Contract, Renewable

Responsibilities :

• Develop and maintain standard operating procedures relevant to the portfolio
• Co-ordinate the regulatory obligations (initial submissions, amendments, re-certification, reports, ad-hoc correspondence, trial registry registration and updates) of the VM-CTU for all supported trials estimated 5 trials per annum
• Work in conjunction with Trial Study Coordinators to obtain necessary documents for submission
• Coordinate regulatory activities with VM-CTU Project Manager and Protocol Development Specialist to meet the regulatory submission deadlines
• Work with individual trial PIs for development, regulatory submissions, distribution of clarification memos, letters of amendment and maintenance of read acknowledgements
• Liaise with Regulatory and Ethics Authorities for administrative matters
• Maintain eTMF for each clinical trial supported by the VM-CTU including but not limited to CV updates and GCP training certification tracking
• Maintain standard operating procedures Masterfile for the VM-CTU
• Oversee the development of the Trial Monitoring Plans for each trial in conjunction with the trial Clinical Research Associate and track monitoring reports and resolution of findings with the Site Study Coordinators
• Report writing in accordance with Funder, Sponsor and Regulatory Body requirements

Minimum Requirements :

TO APPLY :