13-07-2009 | EXPIRA LA 19-07-2009
Job expirat
• Manages and controls the regulatory process;
• Submits regulatory files for new product as early as possible for National and Centralized Procedure;
• Provides Health Authorities with required additional information connected with regulatory process;
• Plans and dates budgets for mandatory re-registrations;
• Plans submitting of product files updates;
• Follows up on the re-registration process and eliminates any drawbacks which might threat product availability;
• Secures pharmaco-vigilance activity;
• Maintains the relationships with the Regulatory, Government and Certification Authorities/Bodies;
• University Degree – Medicine or Pharmacy
• 1 - 2 years experience in Regulatory Affairs activity (generic manufacturing company professional experience is considered an advantage);
• Perfect knowledge in national and international regulatory procedures (national, EU and non-EU market);
• Driving license B;
• Fluency in English (written and verbal);
• Good computer skills;
• Ability to meet deadlines and to work in a team;
• Analytical skills;
If you are interested in this challenging position please send your
CV and Letter of Intent at recruitment@expand.ro no later than 1st of July 2009. Only the suitable candidates will be contacted for an interview.
If you are interested in this challenging position please send your
CV and Letter of Intent at recruitment@expand.ro no later than 1st of July 2009. Only the suitable candidates will be contacted for an interview.
