Regulatory Affairs Specialist (f/m/x)

O nas

FIRMA BIOTON jest pierwszym w Polsce i jednym z 8 światowych producentów substancji aktywnej insuliny ludzkiej otrzymywanej na drodze biotechnologicznej, jak również producentem oraz dystrybutorem na rynkach międzynarodowych form gotowych leczniczych produktów insulinowych przeznaczonych dla Pacjentów.

Celem Firmy BIOTON jest osiągnięcie statusu preferowanego dostawcy kompletnych rozwiązań diabetologicznych wśród Pacjentów, lekarzy oraz społeczności diabetologicznej.

Filozofią Firmy Bioton jest dbanie o zdrowie Pacjentów, ale także wysoka troska o Pracowników.

W związku z tym, szereg benefitów wzbogaconych jest o dodatkowe opcje: ubezpieczenie na życie posiada opcję Global Doctors (leczenie przewlekłych chorób poza granicami kraju), a pakiet medyczny zawiera opcję opieki medycznej dla rodziny.

Miejsce pracy: Macierzysz (pow. warszawski zachodni)

Region: mazowieckie

Opis stanowiska

Twój zakres obowiązków

• Preparation of regulatory documentation for the Company's medicinal products intended for registration in Poland and international markets, in compliance with applicable local regulatory requirements.
• Preparation and submission of regulatory dossiers within national and European procedures, including National Procedures (NP), Decentralised Procedures (DCP), and Mutual Recognition Procedures (MRP).
• Preparation of regulatory documentation for the Company's medical devices intended for international registrations, in accordance with local regulatory requirements.
• Preparation and review of product information texts, labeling materials, and artwork.
• Monitoring changes in regulatory legislation and ensuring documentation compliance with current requirements.
• Liaising with regulatory authorities and external partners regarding the registration and lifecycle maintenance of medicinal products and medical devices.
• Updating internal procedures and regulatory processes in line with applicable legislation and guidelines.
• Close cooperation with internal departments, including R&D, Manufacturing, Marketing, and Quality Control, to support regulatory activities and product lifecycle management.

Wymagania

Nasze wymagania

• University degree in Pharmacy, Biotechnology, Chemistry, Food Technology, or a related scientific discipline.
• Minimum of 1 year's experience in Regulatory Affairs, preferably involving medicinal products and/or medical devices.
• Very command of English, both written and spoken; knowledge of an additional foreign language will be considered an advantage.
• Ability to manage multiple projects simultaneously and effectively prioritize tasks.
• Strong organizational skills and the ability to work efficiently under tight deadlines.

Oferujemy

To oferujemy

• Employment with a well-established and respected pharmaceutical company.
• Opportunities for professional growth through involvement in projects supporting international markets.
• Collaboration with a highly experienced team of Regulatory Affairs and pharmaceutical industry experts.
• Comprehensive benefits package, including a flexible benefits platform, extensive private medical care, employer-funded life insurance, and a subsidized sports card.
• Employee Pension Program (PPE).

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