Junior Medical & Regulatory Affairs Manager

Your responsibilities

• Development and implementation of regulatory strategies for new and existing products
• Documentation management for new products registrations, renewals and post-registration variations in national and European procedures (MRP/DCP)
• Preparation of good quality translation of texts for CP products
• Interaction with regulatory agencies to expedite approval of registration procedures
• Review and approval of promotional material for compliance with regulations
• Preparation of educational materials
• Management of artworks verification and approval process and its timely implementation
• 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 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

Our requirements

• Bachelor's degree in Life Sciences (Pharmacy, Biology, Chemistry, Biochemistry)
• Minimum of 4 years in Regulatory Affairs within pharmaceutical industry, including medicinal products, medical devices, cosmetics and food supplements
• Familiarity with pharmacovigilance regulations
• Comprehensive understanding of regulatory frameworks and submission processes, including national and European regulations
• Excellent communication skills, organizational skills and attention to detail
• Fluent in English, both written and spoken
• Demonstrated team spirit and ability to work in matrix environment

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

Your primary responsibilities will include ensuring regulatory activites, 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.