Regulatory Planning Specialist
Miejsce pracy: WarszawaManpower (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!
Job Tasks:
- Support maintaining integrated ERMC submission and resource planning and forecasting by collecting and compiling relevant submission planning information, support resource assignment and scope discussions/decisions.
- Identify gaps / areas for clarification to be raised with stakeholders (e.g. CMC & Global Labeling, EMEA TA, LOCs and other ERMC team members). Liaise with stakeholders as agreed to collect input/clarification for ERMC planning.
- Collaborate with other ERMC sub-teams such as lifecycle Management, Data Management & Compliance and Labeling Management for activities and aspects related to the ERMC planning.
- Support monitoring of resource planning and raise potential conflicts.
- Support collection and compilation of reporting and metrics overviews • Support optimization of ERMC planning processes and tools.
Requirements:
- General understanding of the pharmaceutical industry and regulatory environment in drug development and/or marketed products.
- High-level Regulatory submission requirement knowledge – procedures, timelines and requirements (minimum 2 years)
- Ability to interpret guidance as they apply to submissions in the countries in scope
- Understanding of compliance requirements and ability to influence outcomes
- Very good English skills (C1)
- Computer literacy in terms of systems, databases and programs
Offer:
- Opportunity to work for a global Big Pharma company
- Stable job environment
- International team
- Benefits package
- Developmental options within the team
- Hybrid or remote job
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
