For our Client, a company in the pharmaceutical industry, we are currently looking for a person for the position of Regulatory Specialist. If you have experience in the pharmaceutical industry and regulatory affairs and you communicate fluently in English, we are looking for you.
what we offer- employment based on a temporary contract
- hybrid work system
- flexible working time
- opportunities for professional development in an international environment, in one of the leading pharmaceutical companies
- benefits to choose from (private healthcare, sports card, etc.)
- 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)
- 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 and US
- 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 the improvement opportunities for CMC Regulatoryprocesses, policies and systems
- relevant experience in regulatory affairs in the pharmaceutical industry (min. 1-2 years)
- excellent knowledge of English (min.B2/C1)
- experience in authoring module III of a medicinal product - required for the senior position
- education in pharmaceutical or life sciences
- flexible and analytical thinking
- communicative and team player
Employment agency entry number 47
this job offer is intended for people over 18 years of age
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