The position

As of now we are seeking a Regulatory Affairs Operations Manager to join our team in RCV (Regional Center Vienna) for 12 months. This role requires a dynamic individual who is a fast learner, can handle complexity, and has a strong background in clinical development, clinical trial applications, and regulatory affairs.

Tasks & responsibilities

• Lead and manage regulatory affairs (RA) projects, ensuring they are completed on time
• Serve as a business partner for Clinical Development & Operations
• Manage and supervise DSUR submissions within the RCV
• Stay updated on the latest digital trends and integrate them into our processes where applicable
• Support and conduct RA-specific trainings using state of the art methods and prepare and adjust corresponding training materials
• Maintain and manage RA-internal databases in scope, ensuring all data is accurate and up to date

Requirements

• Proven experience in clinical development and clinical trial applications
• Experience in regulatory affairs, preferably within the pharmaceutical industry
• Ability to manage and lead projects effectively
• Strong affinity for database management and regulatory intelligence
• Fluent in English, German is an asset

Your Benefits

• Flexible working time models/home office depending on the position
• Additional off-days (bridge-days) for more leisure time
• Staff restaurant with a variety of lunch options for your daily well-being
• Position specific training opportunities for your personal and professional growth
• Comprehensive health promotion, sustaining your health in the best possible way

The minimum gross annual salary according to the collective bargaining agreement for this position is EUR 46.305 (full time). For the actual salary the industry benchmark as well as your qualifications and experiences are taken into consideration. 

We are looking forward to receiving your application online!

By uploading your application documents via our application portal, we can treat your data confidentially and in compliance with the GDPR.
Do you have any additional questions about the position? Your HR Recruiting Manager for this position is Katrin Spögler.

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