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Regulatory Affairs Manager

Currently we are looking for a person for the position: Regulatory Affairs Manager  
Place of work: Warsaw  
Contract type: Fixed-term contract (18 months) 

Tasks and responsibilities

  • Lead of the local Regulatory Affairs team. 
  • Manage registration activities in Poland (NP, DCP and CP procedures). 
  • Manage allocated products, processes and databases. 
  • Execute strategy for new submissions in the country and ensure timely and successful submissions. 
  • Ensure Marketing Authorization maintenance in line with local requirements and global standards (including safety variations, Educational Materials, DHPCs). 
  • Provide expertise and knowledge of regulatory environment and local Health Authorities. 
  • Foster close relationships with relevant Authorities and other key stakeholders. 
  • Provide input to Global RA, Local and Regional RA concepts/strategies/projects. 
  • Ensure adherence to BI and international compliance rules as well as to local legislation in allocated areas of Regulatory Affairs. 
  • Contribute to CAPA process as appropriate. 
  • Perform translation activities. 
  • Ensure new Regulatory Intelligence is captured via an Impact Assessment and communicated appropriately. 
  • Constant tracking of all compliance parameters for allocated products and processes (KPIs). 
  • Support Marketing by preparing short versions of the Summary of Product Characteristics. 
  • Plan and manage RA budget and spending. 

About our future employee 

  • University scientific degree  
  • Knowledge of local and international regulatory affairs regulation 
  • Relevant experience in pharmaceutical industry/CRO is an asset 
  • Good command of English language 
  • Organisational and communication skills 
  • Proactive attitude 
  • Team- and networker 
  • Thoroughness 
  • Strategic thinking 
  • Ability to judge a case 
  • Ability to lead & learn 

What we offer

In this position, we offer employment based on a fixed-term contract (18 months), great opportunities for professional development, and a competitive bonus system.

Additionally, we offer: 

  • Remuneration adequate to the level of experience and competence 
  • Independence in daily activities 
  • Company car, phone, laptop 
  • Opportunities for improvement and professional development 
  • Package of non-salary benefits (medical care, life insurance, Multisport card, My Benefit cafeteria) 

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