Regulatory Affairs Professional

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.