Regulatory Affairs Specialist Global Specialty

Vor 5 Tagen

Bad Vilbel, Deutschland Stada Vollzeit

Die STADA Arzneimittel AG kümmert sich weltweit als vertrauensvoller Partner um die Gesundheit der Menschen. Ursprünglich von Apothekern gegründet, sind wir einer der führenden Hersteller von hochwertigen Pharmazeutika. Mehr als 12.300 Mitarbeiterinnen und Mitarbeiter weltweit leben unsere Werte Integrity, Entrepreneurship, Agility und One STADA, um unsere ambitionierten Ziele zu erreichen und um erfolgreich die Zukunft von STADA zu gestalten.- Unser globaler Standort, STADA Arzneimittel AG befindet sich in Bad Vilbel bei Frankfurt am Main.**Regulatory Affairs Specialist Global Specialty Development (M/F/d)**
- Bad Vilbel | Deutschland| Vollzeit | Unbefristet**Your Tasks**:

- Post-approval variations/submissions (Lifecycle Management)
- Handling of dossier documents in document management software
- Preparation of eCTD sequences with publishing software
- Initiation of change control procedures for variations
- Maintenance of entries in regulatory information database (RIMS): procedure tracking, Extended EudraVigilance medicinal product dictionary (xEVMPD) submissions
- Organization of project trackers for registration and variation procedures
- Information of external partners and affiliates about status of regulatory procedures
- Dossier comparison EU vs non-EU
- Maintenance of Product Information (PI) in 25 EU languages:

- Update of PI in accordance with reference product text and compliance with Quality Review Document templates
- Co-ordination of PI text translations for Marketing Authorization Applications (MAA) and variation procedures
- Request of certificates and preparation of statements for external partners
- Artwork review and compliance check with EMA-approved mock-ups and EC guidance
- Maintenance of marketing status information of biosimilar products

**Your Qualifications**:

- University degree (BA/Master): Science Degree (Pharmacy, Biotechnology, etc.)
- IT affinity
- Proactive organization and communication, flexibility, team spirit
- Excellent knowledge of English, another language is a plus
- Experiences in the following areas is of advantage
- European drug regulatory affairs (recombinant biologicals) and the centralized procedure (EMA), experience with other Health Authorities
- Regulatory intelligence software, publishing tools and document management software (preparation of eCTDs)
- Product information texts and the linguistic review process for centrally authorized products

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