Medical & Regulatory Affairs Junior Manager

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 | Permanent

We are seeking a diligent Regulatory Affairs Junior Manager to be part of Regulatory Team.

Your primary responsibilities will include ensuring our company’s compliance with all regulatory bodies, understanding upcoming regulations and their impact on our operations, and developing and implementing plans to meet those requirements.

Our ideal candidate has a strong understanding of regulatory guidelines and standards in pharmaceutical industry.

Responsibilities

• Development and implementation of regulatory strategies for new and existing products
• Coordination, preparation, or review regulatory submissions for national and European procedures
• Providing guidance to the company regarding the regulatory requirements
• Ensure compliance with regulatory standards and guidelines
• Maintenance of current knowledge of relevant regulations, including proposed and final rules
• Interaction with regulatory agencies to expedite approval of pending registrations
• Management and control of regulatory documentation
• Advice on and coordination the preparation of documents required for regulatory submissions
• Review label, advertising, 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 and medical devices
• Participates in meetings and other project related meetings according to the company needs
• Act as a mentor to new or junior colleagues within regulatory team. Responsibilities could include helping in assigning work; coaching / training; providing instructions; developing tools and processes to help daily work; helping in maintaining high quality of work of regulatory
• Support Regulatory Country Intelligence activities
• Maintenance of regulatory database

Experience and Required Skills / Competencies