Informacje o stanowisku

Opis stanowiska pracy

Manpower (Agencja zatrudnienia nr 412) to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku jesteśmy od 2001 roku i obecnie posiadamy prawie 35 oddziałów w całym kraju. Naszym celem jest otwieranie przed kandydatami nowych możliwości, pomoc w znalezieniu pracy odpowiadającej ich kwalifikacjom i doświadczeniu. Skontaktuj się z nami - to nic nie kosztuje, możesz za to zyskać profesjonalne doradztwo i wymarzoną pracę!

• Regulatory strategy: provide crucial support to RSIL and RRL in navigating complex regulatory landscapes and optimizing product strategies
• Stakeholder collaboration: drive alignment between regional and global strategies by actively engaging in collaborative working groups and fostering strong relationships with regional stakeholders and LOCs
• Documentation and processes: lead the development of streamlined regulatory submission processes and ensure meticulous review and management of regulatory documents, ensuring adherence to strict timelines and high-quality standards
• Clinical trials: offer expert guidance on CTA documents and deliver operational excellence in managing the assembly and submission of clinical trial applications, ensuring seamless execution of regulatory requirements
• Marketing authorization: play a pivotal role in supporting registration processes and maintaining dossier readiness, overseeing the preparation and submission of regulatory documentation with precision and efficiency
• General support: provide invaluable regulatory insight and support, ensuring compliance with regulatory standards, and representing Regulatory in cross-functional teams, while staying abreast of evolving regulatory landscapes

• Bachelors Degree in Pharmacy, Chemistry, Medicine, or Biotechnology
• 2+ years of experience in regulatory affairs within the pharmaceutical industry
• General understanding of the pharmaceutical industry and regulatory environment in drug development and/or marketed products
• High-level knowledge of regulatory submission requirements, including procedures, timelines, and documentation
• Ability to interpret guidance and apply it to submissions in relevant countries
• Understanding of compliance requirements with the ability to influence outcomes
• Proficiency in English (C1 level)
• Computer literacy, including experience with systems, databases, and relevant software
• Self-driven and collaborative, with experience working in multi-functional teams
• Attention to detail and exceptional organizational skills

• Opportunity to work for a global Big Pharma company
• Stable job environment
• International team
• Benefits package
• Hybrid or remote job

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