Medical & Regulatory Affairs Junior Manager

Your 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

Our requirements

• Bachelor's degree in Life Sciences/ health disciplines (Chemistry, Pharmacy, Biology, Biochemistry)
• 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
• Comprehensive understanding of regulatory frameworks and submission processes, including national and European regulations
• Excellent communication skills, both verbal and written
• Strong attention to detail and excellent organizational skills
• Project coordination (management) experience
• 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 our companys 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.