Informacje o stanowisku

For our Client, one of the largest pharmaceutical companies in the world, we are looking for a Senior Regulatory Specialist. If you have relevant experience and you are ready for new professional challenges, apply for this role.

What we expect

• Relevant experience in regulatory affairs, pharmaceutical industry (familiarity with post-approval CMC regulatory procedures and ICH CTD documentation)
• Professional experience in the pharmaceutical/medical industry
• Bachelor’s or Masters degree in biotechnology, chemical technology, pharmacy, chemistry or other related science or technical field
• Fluency in English
• Understanding of the pharmaceutical industry, drug development environment, and regulatory processes
• Strong verbal and written communication skills
• Team player

What we offer

• Temporary employment contract
• RandstadPlus - a system of benefits (sports card, private medical care, discounts on online shopping)
• Hybrid model work (2 days at work, 3 days at home)
• Opportunity to participate in trainings and improve skills
• Development opportunities within the company structure
• Work culture based on respect, honesty, transparency, and focusing on consumer needs
• Managing multiple CMC variations and source transfers for Finished Products, Intermediates, and Active Pharmaceutical Ingredients for pharma, biopharm, and vaccines products (work with the CTD Module 3, Quality part of the dossiers)
• Managing assigned projects: define and agree regulatory strategy, complete data assessment to ensure authored regulatory dossier is in compliance with regulatory processes and external requirements for local markets e.g. Europe, US, and International countries
• Working with colleagues in Global Supply Chain, Global Regulatory Groups, and Local Operating Companies in markets worldwide to deliver high-quality dossiers on time
• Building and maintaining good relationships with internal and external stakeholders
• Monitoring regulatory intelligence and acting proactively on identified changes to the regulatory requirements
• Identifying improvement opportunities for CMC Regulatory processes, policies, and systems

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