Regulatory And Clinical Start Up Specialist (Biotech)

Progressive; München; Vor Ort; EUR 40.000 - 55.000; Vollzeit

Zusammenfassung

A biotechnology firm in Munich is seeking a Regulatory And Clinical Start Up Specialist to oversee global clinical trials and review regulatory submissions. The ideal candidate has a university degree in a relevant field and 1-2 years of experience in the pharmaceutical industry. Strong English communication skills and proficiency in office software are required for this full-time, entry-level position.

Qualifikationen

• Minimum of 1-2 years professional experience in the pharmaceutical industry.
• Academic degree in natural sciences is an advantage.

Aufgaben

• 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.

Kenntnisse

Fluent in written and verbal English

Excellent verbal, written, organizational and interpersonal skills

Strong follow up & time management skills

Ausbildung

University degree or professional education in Pharmaceutical/Medical Technology

Tools

MS Office Programs

SAP

Zoom

Teams

Jobbeschreibung

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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