Regulatory Scientist

5 dni temu

Warszawa, Polska ManpowerGroup Sp. z o.o. Pełny etat

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


Main responsibilities:
  • 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
Requirements:
  • Bachelor's 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
Offer:
  • Opportunity to work for a global Big Pharma company
  • Stable job environment
  • International team
  • Benefits package
  • Hybrid or remote job

The offer applies to permanent work.

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