2022-07-29 11:26:48

Regulatory affairs specialist

CVMarket.lt klientas
1800 - 2000 €/m Net

Job Description

  • Act as LOC Regulatory Affairs Specialist;
  • Support global products or coordinate local products regulatory submissions to local Regulatory Authority;
  • Own communication with local Regulatory Authorities, Global Regulatory Authorities and MCO RA/QA/PV Head;
  • Guarantee accuracy and adherence to local Regulatory Authorities legislation, guidelines and other relevant documents and proactively inform management on relevant changes;
  • Responsible for timely preparation, submission and appropriate follow-up of Regulatory submissions (new Marketing Authorizations, variations, renewals);
  • Responsible for handling of lifecycle changes through Takeda’s databases;
  • Responsible for update of Product Information, artworks, mock-ups;
  • Provide regulatory input and advice on new product launches and other regulatory activities;
  • Build relationships with Health Authorities, understand their internal workings, maintain open communication channels and respond with urgency and accuracy to Health Authority requests. Active involvement and participation at Industry Associations where possible.


  • Advanced degree in pharmacy;
  • Experience and proven track record in regulatory affairs;
  • Experience of working in a matrix management environment;
  • Deep understanding of EU and local laws, regulations and Industry codes related to RA, GVP;
  • Proven conflict management and independent problem-solving skills;
  • Advanced process management skills;
  • Drives performance of self and others;
  • Highest ethical standards;
  • Excellent communication and collaboration skills with external and internal stakeholders;
  • Proven experience in successfully managing several projects at the same time;
  • Job experience in Pharmaceutical company in last 2-3 years.

Company offers

  • An opportunity to work in a one of the top 20 largest pharmaceutical companies in the world by revenue;
  • Friendly environment; 
  • Office in a convenient location;
  • Career opportunities;
  • Motivating salary.


Please send your CV in English.

Only selected candidates will be informed. Confidentiality is guaranteed.

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