Job Description

We’re Hiring at Doctors Pharma!
Doctors Pharma (DP), a startup pharmaceutical manufacturing company, is expanding its Regulatory Affairs team. Our headquarters is in Jeddah, Saudi Arabia, and we are building a passionate team to support innovation, quality, and patient-centered healthcare across Saudi Arabia and the MENA region.

🔹 Job Vacancy: Senior Regulatory Affairs Specialist
Location: Jeddah, Saudi Arabia
Type of Contract: Full-time | On-site
Eligibility: Saudi Nationals Only
Reference Code: REF: RA
We are looking for a motivated and detail-oriented Senior Regulatory Affairs Specialist to support regulatory activities, product registration, and medical affairs operations. The role will help ensure that product dossiers and submissions meet SFDA requirements and support the company’s growth in the Saudi pharmaceutical market. SFDA’s submission guidance recognizes the eCTD as the electronic equivalent of the CTD for regulatory submissions.

🔹 Role Summary:
The Senior Regulatory Affairs Specialist will manage and coordinate regulatory submissions, maintain product registration documentation, and liaise with internal stakeholders to support timely approvals and compliance. The successful candidate will have practical knowledge of SFDA regulations, CTD/eCTD dossier formats, and the regulatory environment in Saudi Arabia.`

🔹 Key Responsibilities
Prepare, compile, review, and maintain regulatory dossiers in CTD/eCTD format.
Support product registration, renewals, variations, and post-approval regulatory activities.
Coordinate SFDA submissions and follow up on regulatory queries, requirements, and approvals.
Ensure regulatory documentation is complete, accurate, current, and compliant with applicable requirements.
Collaborate with Quality, Manufacturing, Supply Chain, Medical, and Commercial teams on regulatory matters.
Monitor regulatory updates and assess their impact on company products and activities.
Support medical documentation, product information, labeling, and artwork review as required.
Maintain regulatory databases, submission trackers, and product registration records.
🔹 Qualifications & Requirements
Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, or a related health field; advanced qualifications are an advantage.
Minimum 1–3 years of experience in Regulatory Affairs, ideally within the Saudi pharmaceutical market.
Demonstrated experience supporting SFDA submissions and approvals.
Strong understanding of SFDA regulations and Saudi pharmaceutical registration requirements.
Familiarity with CTD/eCTD dossier formats; awareness of GCC regulatory frameworks is an advantage.
Detail-oriented, with strong documentation and organizational skills.
Strong Arabic and English communication skills.
Ability to manage multiple projects, priorities, and deadlines.
Proficiency in Microsoft Office and regulatory information tools.