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Regulatory Affairs Specialist

jamjoompharma/careers

Riyadh

On-site

SAR 150,000 - 200,000

Full time

Today
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Job summary

A leading pharmaceutical company in Saudi Arabia seeks a Regulatory Affairs Specialist to support the registration and compliance of pharmaceutical products. The ideal candidate will manage product registrations and serve as the liaison with the SFDA. A BSc in Pharmacy or PharmD, along with 1-3 years of experience in Regulatory Affairs, is required. Strong communication skills in Arabic and English are essential for this role.

Qualifications

  • 1-3 years of Regulatory Affairs experience in the Saudi market.
  • Familiarity with SFDA e-services and obligations.
  • Experience with eCTD/RIM is advantageous.

Responsibilities

  • Manage product registrations, renewals, and pricing submissions to SFDA.
  • Serve as the primary liaison with SFDA.
  • Ensure compliance of promotional and non-promotional activities with SFDA regulations.

Skills

Regulatory Affairs
English communication
Arabic communication
Attention to detail
Organizational skills

Education

BSc Pharmacy / PharmD
Job description
About the Role

Support the registration, maintenance, and compliance of pharmaceutical products with the SFDA and regional health authorities—driving timely submissions, approvals, and adherence to all regulatory requirements.

Key Responsibilities
  • Manage product registrations, renewals, variations, and pricing submissions to SFDA and GCC authorities.
  • Serve as the primary liaison with SFDA for Scientific Office and Regulatory Affairs communications, including handling and closing authority queries.
  • Oversee market maintenance obligations, such as shortage notifications and related compliance requirements.
  • Ensure compliance of both promotional and non-promotional activities (materials, events, digital content) with SFDA regulations.
  • Coordinate with QA, Medical, Marketing, and Supply Chain teams to collect documentation, support submissions, and maintain accurate records and archives.
  • Monitor regulatory updates and translate them into practical internal actions (e.g., SOPs, templates, brief trainings).
Qualifications
  • BSc Pharmacy / PharmD
  • 1–3 years of Regulatory Affairs experience in the Saudi market; export market exposure is a plus.
  • Familiarity with Scientific Office obligations and SFDA e-services; working knowledge of eCTD/RIM is an advantage.
  • Strong organization, attention to detail, and stakeholder communication (Arabic & English).
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