At STADA we pursue our purpose “Caring for people‘s health as a trusted partner” worldwide. Originally founded by pharmacists, we are a leading manufacturer of high-quality pharmaceuticals. More than 12,300 employees around the globe live our values Integrity, Entrepreneurship, Agility and One STADA to achieve ambitious goals and shape the successful future of STADA.

STADA Poland, as a part of STADA Group, follows the Group’s philosophy. We have a wide product portfolio including analgesics, urology medicines, medicines for treatment of disorders in central nervous system, diabetes and diseases of cardiovascular system. STADA Poland also offers a wide range of non-prescription consumer healthcare products for pain relief, menopause symptoms, glycaemia level control and skin care and treatment products. The educational activities in the field of pain treatment in the last few years, allowed us to build a position of a Trusted Partner in Pain Treatment. We are constantly enriching our portfolio, and at the same time, we are participating actively in educational activities in other therapeutic fields.

Medical & Regulatory Affairs Junior Manager   

Warszawa | Poland (PL) | Full-time | Fix-term 

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

Experience and Required Skills

• 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

We are looking for talents with expert knowledge and an entrepreneurial spirit that enjoy working collaboratively in a global team. We are pleased to get to know you better. Please use our online portal to submit your application: jobs.stada.com