Regulatory Affairs Specialist

Opis stanowiska podany przez pracodawcę:

Regulatory Affairs Specialist
Warszawa
NR REF.: 1183618

Key responsibilities: 

• Preparing registration submissions and post-approval variations for medicinal products
• Managing CMC (Chemistry, Manufacturing and Control) Variations for Finished Products and Active Pharmaceutical Ingredients
• Maintaining Product Information Files (PIF) for cosmetic products and submit notification to PL HA for Medical Devices
• Performing regulatory activities for assigned brands / product categories (medicinal products/cosmetics/medical devices) 
• Coordinating artworks updates as part of variations submission or other regulatory updates or new product launch and liaison with other functions to manage implementation
• Verifying and approving promotional materials for assigned brands
• Liaising with authorities responsible for the Marketing Authorization of concerned products in Poland
• Tracking local and the EU legislation related to authorization and maintenance of authorization for different categories of products.
• Publishing eCTD sequences for new MAA application/variations for medicines
• Back-up for reporting safety-related information to Global Safety Team (via TrackWise)
• Preparing draft answers to medical enquiries for assigned brands

Requirements:

• Minimum 3-years of regulatory experience with medicinal products 
• Higher education in medical, pharmaceutical, chemical, biological or related fields
• Very good knowledge of Polish and EU regulations regarding medicinal products 
• Excellent organizational and planning activities 
• Good communication skills 
• Fluent in spoken and written English

If you39re interested in this role, click 39apply now39 to forward an up-to-date copy of your CV, or call us now.

Hays Poland sp. z o.o. is an employment agency registered in a registry kept by Marshal of the Mazowieckie Voivodeship under the number 361.

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