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Regulatory Affairs Professional

ManpowerGroup Sp. z o.o.

Warszawa, mazowieckie

ManpowerGroup Sp. z o.o.

Regulatory Affairs Professional

Miejsce pracy: Warszawa

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:

  • Participating actively in internal process improvements.
  • Communicating effectively with other ERMC sub-teams and Stakeholders
  • Supporting other team members in Data Management activities
  • Data and record management (ensuring all assigned records in global systems and databases are filled-out and regional records are set up correctly and in time), including but not limited to:
 – InSight: responsible for timely and accurate update of impact assessment for assigned CMC variations as well as update throughout submission and approval process (as applicable); responsible for timely and accurate update of actual submission and approval dates for assigned Labeling variations (as applicable); responsible for timely provision of information and approved PI for XEVMPD notification (EEA only)– LIFT: responsible for timely impact assessment entry for assigned Labeling variations; timeline adjustments and extensions when applicable; set-up records for locally triggered changes as applicable For MEWA multi-country pack: set-up records for new Marketing authorization applications (MAA) and request reference country labeling designation for MEWA pack
– GRAIL: responsible for archiving all relevant HA communications related to the assigned submissions; submitting variation dossiers, including response to HA questions and eCTD closing sequences, in respective local HA portals, as applicable Requirements:
  • Good understanding of the Pharmaceutical Industry and Regulatory Experience in Drug Development and/or maintenance of Marketed Products
  • Intermediate knowledge of Local and Regional Regulations and Guidance in the region related to full drug life cycle
  • Awareness of the scientific principles (CMC, clinical and non-clinical) applicable to the specific products
  • Knowledge of quality and supply chain and potential impact to regulatory procedures and status of products
  • Knowledge of regulatory systems (e.g. InSight, LIFT, GRAIL)
  • English skills at C1 level

Offer:

  • Work for one of the global top pharma companies
  • Daily routine in international environment, opportunity to practice English skills
  • Opportunity to gain valuable experience
  • Co-creating a new regulatory HUB in Poland
  • Health insurance, life insurance, MultiSport
  • Hybrid work (for people from Warsaw) or remote (for distant locations)

The offer applies to permanent work.
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