Pharmacist – Regulatory Affairs

Protectol Health; Dhahran Compound; On-site; SAR 150,000 - 200,000; Full time

Job summary

A healthcare company in Dammam is seeking a Saudi national Pharmacist (Fresher) to join their Regulatory Affairs team. This role involves assisting in regulatory submissions, maintaining regulatory documents, and collaborating with various departments. Ideal for fresh graduates with a Bachelor’s in pharmacy, the position offers exposure to pharmaceutical regulatory affairs and the chance to build a career in this field under the guidance of experienced professionals.

Qualifications

• Saudi National status is mandatory.
• Fresh graduates are encouraged to apply.
• Registered or eligible for registration with SCFHS.

Responsibilities

• Assist in preparing and submitting regulatory documents.
• Support compilation of eCTD dossiers for products.
• Coordinate with internal departments for regulatory documents.
• Maintain organized regulatory documentation.

Skills

Good communication skills

Coordination skills

Documentation skills

Proficiency in MS Office

Education

Bachelor’s degree in pharmacy

Job description

Pharmacist – Regulatory Affairs (Fresher)

Location: Dammam, Kingdom of Saudi Arabia

Job Summary

We are seeking a Saudi national Pharmacist (Fresher) to join our Regulatory Affairs team in Dammam. The role will support regulatory submissions, documentation, and coordination with the Saudi Food and Drug Authority (SFDA) under the guidance of senior regulatory professionals. This position is ideal for newly qualified pharmacists looking to build a career in pharmaceutical regulatory affairs.

Key Responsibilities

• Assist in preparing and submitting regulatory documents and responses to SFDA inquiries under supervision.
• Support compilation and maintenance of eCTD dossiers for medicinal products and health supplements.
• Coordinate with internal departments (Quality, Supply Chain, Marketing) to collect required regulatory documents.
• Help review product variations and maintain proper regulatory records as per SFDA guidelines.
• Track submission statuses, approvals, and regulatory timelines to ensure continuity.
• Assist in maintaining valid product registrations, including updates to PILs, SmPCs, and artworks.
• Support post-approval activities, renewals, and life cycle management of registered products.
• Maintain organized regulatory documentation and assist during audits or inspections.
• Stay informed about basic local regulatory requirements and updates in KSA.

Qualifications & Requirements

Saudi National (Mandatory):

• Bachelor’s degree in pharmacy (Fresh graduates are encouraged to apply).
• Registered or eligible for registration with the Saudi Commission for Health Specialties (SCFHS).
• Basic understanding of pharmaceutical regulatory affairs and SFDA requirements (academic or internship exposure acceptable).
• Willingness to learn eCTD processes and regulatory submission systems.
• Good communication, coordination, and documentation skills.
• Proficiency in MS Office applications.
• Ability to work collaboratively in a team-oriented environment.

Preferred (Not Mandatory):

• Internship or training exposure in Regulatory Affairs or pharmaceutical industry.
• Basic knowledge of product registration or variation processes in KSA.
• Strong attention to detail and compliance mindset.