Regulatory Affairs Specialist KSA

الوصف الوظيفي

The Regulatory Affairs (RA) Specialist will fulfill the local regulatory activities to maintain & keep the RA portfolio compliant for KSA (70 %) and UAE (30 %).

You will support RA Manager on operational RA submissions and assist in ensuring continuous compliance with all RA and Safety Officer responsibilities, maintaining readiness for audits and inspections by Healthcare Authorities at all times.

You will ensure business continuity by serving as a backup for the RA Manager, as well as for Quality Assurance (QA) and Pharmacovigilance (PV) functions. As Regulatory Affairs, Quality Assurance, and Pharmacovigilance are mandatory functions that must be continuously available on site—including during vacation periods—you will help ensure that at least one qualified RA/QA/PV representative is present on site at all times.

You will provide strategic and operational Regulatory Affairs support for Saudi Arabia to ensure the timely renewal, maintenance, and variation of existing and new products, including prescription products, injectable aesthetics/medical devices, and cosmetics.

It is critical to maintain momentum to ensure ongoing compliance with the constantly evolving SFDA guidelines.

• Manage the entire registration process in ensuring approvals of new products and amendments to products
• Develop and execute registration strategy in close partnership with Global RA & local RA Manager
• Stay abreast of, and ensure compliance with, the continuously evolving, complex, and country‑specific regulatory frameworks in KSA and the UAE
• Ensure compliance with, and maintenance of, existing product licenses.
• Ensure high‑quality, timely regulatory submissions; enhance regulatory intelligence; and develop and maintain databases to simplify local Regulatory Affairs processes, including record retention and submission tracking.
• Ensure that progress of applications and changes to registered details are communicated to local and global stakeholders, as appropriate
• Manage in‑house regulatory files, documentation, and corporate electronic databases. Support projects aimed at process improvement and the development of simplification tools across all Middle East markets, including tracking systems and data management. Assist in internalizing certain Regulatory Affairs activities currently outsourced, such as eCTD preparation, in a phased manner.

• Pharmacist degree/Bachelor degree in Pharmaceutical sciences.
• Saudi Arabia national and licensed pharmacist with MOH registration
• At least 4–5 years of experience in a Regulatory Affairs position, for prescription medicines and medical devices in KSA and UAE
• In-depth understanding of the pharmaceutical industry in Saudi Arabia, with strong connections to the SFDA preferred
• Quality experience and fair knowledge of Pharmacovigilance preferred
• Computer literate, with the ability to manage the entire product registration process, ensuring timely approvals for new products and amendments to existing products
• Proficient in electronic documentation systems
• Arabic, with strong written and verbal English skills

• You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
• You will receive a competitive compensation package with bonus structure and extended benefit package.
• You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take accountability.

• Please apply with an English language CV.
• If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
• The next step is a virtual conversation with the hiring manager.
• The final step is a panel conversation with the extended team.

At Galderma, you’ll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.