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NAOS (Bioderma - Institut Esthederm - Etat Pur)

Regulatory Affairs Senior Expert

5-7 Years
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  • Posted 16 hours ago
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Job Description

MONTHLY SALARY UP TO 1300 USD

The main mission of this role is to ensure regulatory compliance, timely registration, and quality management of products across assigned markets. Key challenges include coordinating across multiple departments and distributors to maintain seamless regulatory filings, managing quality claims effectively, and securing timely documentation.

SCOPE OF WORK:

Middles East Distributes

ROLES & RESPONSIBILITIES:

Regulatory submissions

  • Contribute actively to preparation and filing of regulatory submissions, in collaboration with local distributor, which may require interaction with different distributors departments
  • Ensures execution of the registration plan for assigned products and territories, in collaboration with NAOS team & local distributor
  • Coordinate with local distributors to maintain the validity of the registered products to ensure a continuous supply
  • Request and follow up with HQ to secure all the registration files on time and follow-up registration process till receiving the registration certificates
  • Creating & tracking the portfolio sheets for the countries, keep updating portfolio sheet with updated codes & new registration numbers.
  • Collaborate with internal stakeholders to ensure timely submission of registration files for newly launched items on Armada in alignment with launch plans and follow up distributors to finalize registration across Regulatory Authorities 1-3 months before product availability.
  • Provide the distributor all the needed regulatory documents to ensure smooth business process in the country.

Regulatory Compliance & Quality

  • Manage quality and cosmetovigilance claims in assigned countries, reporting them to headquarters.
  • Following up the quality claims and communicate effectively with the countries the required actions
  • Oversee the product destruction process for confirmed quality claims and issue related credit notes to the distributor
  • Implement necessary process documentation as per requirements

Communication

  • Ensures consistent communication to internal/ external stakeholders, local distributors & partners
  • Builds effective relationships with local distributors based on transparency, trust, and respect.

REQUIREMENTS:

Education/Degree: Master's in Regulatory Affairs or certifications in regulatory affairs

Background including total years of experience: 5 years of experience

Technical skills: Regulatory Knowledge, Document Management, Quality Management, Data Analysis, Communication skills

Languages: English mandatory, Arabic and French will be a plus

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Job ID: 143852719