Oferta wygasa za:18 dni
Tryb pracyHybrydowa
Rodzaj umowyInny
Tryb rekrutacjiRekrutacja stacjonarna
Wymiar etatuPełny etat
BranżaAdministracja biurowa
Your responsibilities
- Coordination, preparation and review regulatory submissions for national and European procedures
- Ensure compliance with regulatory standards and guidelines
- Interaction with regulatory agencies to expedite approval of pending registrations
- Management and control of regulatory documentation, ensuring completeness, accuracy and proper archiving
- Coordination the preparation of documents required for regulatory submissions and responses to authorities questions
- Review labelling and promotional material for compliance with regulations
- Work closely with other departments to ensure that compliance is maintained throughout the company
- Develops/reviews country-specific labelling content for food supplements, cosmetics, medical devices and biocidal products
- Participates in meetings and other project related meetings according to the company needs
- Support Regulatory Country Intelligence activities
- Maintenance of regulatory database and tracking systems
Our requirements
- Bachelor's degree in Life Sciences (Pharmacy, Chemistry, Biology, Biochemistry or related discipline)
- Minimum of 4 years in Regulatory Affairs within pharmaceutical industry (focusing not only on medicinal products but also medical devices, cosmetics and food supplements)
- Familiarity with pharmacovigilance regulations is advantageous
- Good understanding of regulatory frameworks and submission processes, including national and European regulations
- Strong communication skills, both verbal and written
- Strong attention to details and good organizational skills
- Fluent in English, both written and spoken
- Demonstrated team spirit and ability to work in matrix environment
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