Senior Associate - Regulatory Affairs & Quality Assurance

Regulatory Affairs/Clinical Affairs Videnska 119D, Czech Republic


Description


Senior Associate: Regulatory, Quality Affairs, & Safety
Czech Republic

An exciting opportunity to join a dynamic, game-changing team within a multinational selfcare company with a diverse portfolio. The scope of the position is to support regulatory, quality and safety operations to ensure full compliance with quality requirements in the relevant countries. The role has cross country responsibilities with main focus on Czech and Slovak Republic and also provide some support for Hungary. The role will attract a good level of organisation and learning skills and autonomy and responsibility for managing work and priorities. This person will be an integral part of the Regulatory, Quality, Safety team in CZ/SK, aiming to be best in class in the industry, and will have contact with broad number of local and international stakeholder

Responsibilities:
• Registration and maintenance of registration of medicinal products, communication with local regulatory authorities
• Ensuring registration and compliance with legislative requirements for all products of the company (medicines, medical devices, cosmetics, biocides, food supplements), communication with relevant state authorities
• Quality Assurance and quality control of products
• Development and innovation of products
• Mandatory reports to state authorities and internal reports
• Pharmacovigilance – deputy LPPV or LPPV / Pharmacovigilance (Local Contact Person for Pharmacovigilance)
• Distribution – maintenance of GDP (Good Distribution Practice), batch release to distribution
• Support of Quality activities (complaint management, quality systems and processes etc)
• Fulfills other tasks according to the company´s current needs

Requirements:
• Education: University degree (medicine, pharmacy, chemistry)
• Experience: minimum 2 years in Regulatory Affairs position
• Language skills: Active English
• Other expertise: knowledge of current valid legislation in the field of medicines, medical devices, food supplements and cosmetics

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.