Regulatory Affairs Associate

• The Regulatory Affairs Country associate will report to Regulatory Affairs Head Tunisia Libya.

  
  

  The Regulatory Affairs Country associate will be responsible of managing the regulatory strategy (ie: MA Registration) and the post-approval changes dossier to Health Authorities 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 submission of regulatory dossier:
  • Labeling, CMC, administrative, renewal /annual report
  • Site registration
  • Tender

• and /or preparing 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.).

  
  
• Responsible for managing the regulatory strategy
• Ensure regulatory compliance with products overall strategies and  Health authorities country requirements evolution.
• Provide support and communicating information on products to other functions (approvals…)
• Be compliant with all internal and external requirements, procedures and tools.
• Manage activities such as shortages, DHPC, B/R reevaluation, etc.
• Review and validate at country level promotional material with Marketing and Medical in line with Global strategies and policies
• Accountable for keeping the databases updated on a timely basis for portfolio
• Implement in timely manner Regional BU submission 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 COE regulatory team  
• Foster an environment/culture of learning and sharing of best practice within the team

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

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