Regulatory Planning Specialist

Opis stanowiska podany przez pracodawcę:

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!

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

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