ISG Personalmanagement GmbH
01.10.2022 • Mitarbeiter ohne Führungsposition • ab sofort • Ref-Nr: 90.147

Our client is a successful pharmaceutical company with own research and development operating worldwide. High product quality, pursuit for innovation and a high level of customer and service orientation are the key indicators for its success.
We are offering the following unique and challenging career opportunity in the Vienna-office throughout regional countries: Manager Regulatory Affairs (m/f/d) Regional role based in Vienna / Full-time or part-time

Your responsibilities after an intensive onboarding phase:

• Acting as cross-functional team player within peer group and within project teams
• Personal in-depth responsibility for selected products and selected RA projects
• Monitoring and coordination of EU and non-EU regulatory projects
• Support preparation and compilation of registration dossiers for marketing authorization applications (MAA) and life cycle submissions
• Compilation of submission documentation for new applications and life cycle activities in the EU (eCTD format) as well as in non-EU countries according to local requirements
• Act as regulatory contact person for authorities, external partners and in-house functions for assigned products
• Provide regulatory guidance and strategy for life cycle activities
• Support Project Teams involved in the planning of life cycle activities
• Coordination with 3rd parties, as needed, for the preparation of regulatory submissions
• Coordination, review and proof-reading of responses to questions from authorities
• Staying up to date with relevant regulatory and scientific guidelines, directives and regulations
• Planning of regulatory projects including documentation, resources and budget

Your interesting profile:

• Bachelor’s degree in scientific or health discipline, preferably M.S. or higher
• In-depth knowledge in the field of RA and a strong knowledge of EU regulations
• Experience of EU regulatory framework and Regulatory Life Cycle Management with respect to business needs
• Self-motivated person and excellence in work planning
• Strong sense of responsibility and attention to detail
• Excellent communication skills in English and motivation to learn German

We offer:

• An international career opportunity for a committed and highly motivated person
• A multicultural, appreciative environment in an internationally operating top company
• Attractive expert role on a full-time basis or part-time, at least 32 hours per week
• The legal base annual salary for this position is at least € 56,000 (full-time basis) with willingness of overpayment depending on your qualifications and relevant experience, additionally performance based premiums and attractive fringe benefits

Are you interested?

Seize the opportunity, take the first step and send your application to Birgit Prochazka quoting the reference 90 147 via eMail or via our ISG career portal ISG-Karriereportal. ISG Personalmanagement GmbH
A-1010 Wien, Universitätsring 14
Mag. Birgit Prochazka, T: +43 1 512 35 05-16
@:bewerbung.prochazka@isg.com