CIVP Affaires réglementaires

The COE Tunisia learner will be responsible for the post-approval changes dossier evaluation, preparation and dispatch to the countries for submission in line with local regulations and planning set up by Global/Regional BU/Country regulatory team.

Specific requirements and responsibilities include:

• According to the country regulatory requirements and planning, assess, coordinate and contribute to the preparation of ready- to- submit regulatory dossier:
  • Labeling, CMC, administrative, renewal /annual report
  • Site registration
  • Tender
• and /or any type of response documents to the Health Authorities questions by interacting with the relevant stakeholders (BU region regulatory, GRA, RSO local medical, local Pharmacovigilance department etc.) and monitoring of dossiers dispatch up to submission.
• Ensure regulatory compliance with products overall strategies and  Health authorities country requirements evolution
• Be compliant with all internal and external requirements, procedures and tools,
• Implement in timely manner Regional BU/country planning dispatch and ensure alignment with RA BU region and country activities
• Maintain a good working relationship with internal and external stakeholders, be a business partner for the BU/Country regulatory team  
• Foster an environment/culture of learning and sharing of best practice within the team