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Regulatory Affairs Specialist

NAOS (Bioderma - Institut Esthederm - Etat Pur)
Jeddah, KSA
Fulltime
Entry
1 months ago
AffairsRegulatorySpecialist
Free

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Overview

Saudi National only

Education And Degree: Bachelor of Pharmacy

Background: 2 to 4 years in regulatory,Technical skills: Microsoft Office, good knowledge in Excel & Word.

Languages: Arabic (is a must) + Fluent in English

Product Registration & Compliance

  • Helps to prepare the registration documents / filing with all the requested information to make files ready for submission in GHAD
  • Tracking the new launches, new updates, and renewals of NAOS products with lifecycle maintenance
  • Ensure full compliance with KSA laws and GCC standards
  • Maintain accurate regulatory records and product databases
  • Help to register needed tools in SABER & obtain COC.
  • Ensure full update and compliance with Saudi / Bahrain regulation

Quality & Cosmeto-Vigilance

  • Monitor all the received quality complaints from all end users (patients – pharmacies – customers) related to any unpleasant issues with products (smell, texture, packing damages…etc).
  • Monitor & follow up the received adverse actions rom all end users (patients – pharmacies – customers) related to any unpleasant side effects appear upon using NAOS products (irritation, breakouts, itching,etc.)

Hq Updates

  • Classify the received product updates & apply the needed for KSA
  • Make sure to track & follow up all the updates received upon the registration file requests

Armada

  • Submit IRF files requests for KSA & BAH
  • Keep tracking the status of files (receival, new dates of receival, cancellation)

Regulatory Intelligence & Communication

  • Monitor changes in local regulatory requirements and update stakeholders accordingly
  • Respond to regulatory queries, objections, or non-conformities raised by authorities

Project Coordination

  • Coordinate with supply chain, commercial, marketing & finance teams when needed
  • As a NAOSian, you continue to be…
  • Demanding and caring — high bar for results, attentive to people.
  • Authentic and courageous — you stand for what you believe and speak the truth.
  • Purpose-driven — motivated by impact on people and the living, not just KPIs.
  • Curious and entrepreneurial — you take initiative, test, and learn.
  • Agile and resilient — you navigate ambiguity and bounce back.
  • People-oriented and collaborative — you build trust and make the team stronger.
  • And you bring with you…
  • A strong sense of service — colleagues, customers, and HCPs first.
  • Sound judgment and integrity — discretion with sensitive matters.
  • Clear, candid communication — simple, audience-aware, kindly delivered.
  • A learning and feedback mindset — open to input, quick to act.
  • Calm under pressure — focused on what truly creates value.
  • Strong interpersonal and cross-cultural skills — trust across functions and cultures.
  • Ready to join by July 2026

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