Stellenbeschreibung

Our offer

• Exciting, self-organized and responsible tasks
• Long-term employment relationship, pleasant working atmosphere in a young, dedicated team
• Flexi time agreement, flexible working time model, work-life balance
• Opportunities for specialization and subject-specific further education and training
• Extremely collegial team with a friendly approach
• Various development opportunities within the Capgemini Engineering Group

Your role

• Evaluate regulatory requirements and provide regulatory strategies when preparing or managing the timely delivery of high quality documentation required for initial marketing authorization applications and dossier updates worldwide
• Identify potential regulatory gaps besides providing risk mitigation and minimization measures during strategic evaluations
• Provide input and collaborate with partners about implementing strategies, ensuring timelines and requirements, or assuring congruency and compliance
• Take over the regulatory lead for defined project tasks.
• Act as representative of regulatory functions in cross-functional project teams and workstreams
• Own the preparation of responses to regulatory relevant queries from various partners and directly interact with regulatory authorities and/or with regulatory functions in the countries

Your profile

• University degree in natural sciences, ideally PhD, or comparable qualification
• Minimum of two years of work experience in pharmaceutical or biotech regulatory affairs
• Proficient in English (oral and written)
• Strong communication, negotiation, and interpersonal skills
• Ability to work in interdisciplinary teams
• Ability to work in a matrix environment
• Ability to interpret scientific data and to construct persuasive regulatory documents

100% remote work within Austria is possible.

The gross annual salary is at least EUR 60.000€ but of course we offer overpayment in line with the market, depending on qualifications and professional experience.

WE LOOK FORWARD TO YOUR ONLINE APPLICATION!
Capgemini Engineering Recruiting Team