For our client, well-known pharmaceutical company based in Poznań we are currently looking for a candidate for a position of Regulatory Specialist (CMC Variations Team). Client offers remote work for candidates from other locations.
• Managing multiple CMC (Chemistry, Manufacturing and Control) Variations assignments for Finished Products and Active Pharmaceutical Ingredients for Pharma and Vaccines products.
• Define and agree strategy, complete data assessment to ensure authored regulatory dossier is in compliance with Company regulatory processes and external requirements for local markets e.g. Europe (for Centralised, Mutual Recognition and Decentralised procedure submissions, US and International countries).
• Working with colleagues in Global Manufacturing & Supply and Local Operating Companies in markets worldwide to deliver high quality dossier on time.
• Monitoring regulatory intelligence and act proactively on identified changes to regulatory requirements.
• Building good relationships with internal and external stakeholders.
• Ensuring all appropriate regulatory aspects for product release and stability are in place, to ensure continuity of market supply.
• 2 to 3 years of relevant experience (in regulatory affairs, pharmaceutical industry, life sciences research, clinical research, pharmacovigilance).
• Bachelor’s or Master's degree in chemistry, pharmacy or other related science or technical field
• Attention to detail, excellent organization and time management skills.
• Excellent written and verbal communication skills in English.
• Ability to think flexibly to meet constantly shifting priorities and timelines and to independently provide solutions to issues.
• Understanding of the pharmaceutical industry, drug development environment, and regulatory processes