Regulatory And Clinical Start Up Specialist (Biotech)

Regulatory And Clinical Start Up Specialist (Biotech)

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Regulatory and Start up Associate/ Specialist

• Responsible for oversight of assigned global clinical trials
• Review of regulatory submission documents and packages
• Support study teams as RA representative
• Preparation of responses to regulatory requests
• Support of regulatory interactions as applicable
• Negotiation of Budgets
• Contract Management

Experience Requirements

• University degree or professional education e.g. Pharmaceutical/Medical Technical Assistant with a minimum of 1-2 years professional experience preferably in pharmaceutical industry (an academic degree in natural sciences e.g. Bachelor would be an advantage)
• Fluent in written and verbal English
• Advanced knowledge and on-hands experience in using office software - e.g. MS Office Programs, SAP, Zoom, Teams etc.
• Excellent verbal, written, organizational and interpersonal skills
• Strong follow up & time management skills

Seniority Level

Entry level

Employment Type

Full-time

Job Function

Health Care Provider

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