مشرف الشؤون التنظيمية

Job description

1.Oversee the preparation, review, and timely submission of regulatory dossiers to ensure accuracy and compliance with SFDA and other relevant authorities.

2.Take full responsibility for building renewal files, including preparation, compilation, follow-up, obtaining renewed certifications, and sharing them with relevant departments within defined timelines.

3.Act as a bridge between the Regulatory Affairs team and external stakeholders, ensuring clear communication and alignment on regulatory matters.

4.Act as a superuser for the team by actively participating in the implementation of the new Regulatory Information Management System and representing the RA-KSA office in system development meetings.

5.Oversee monitoring of regulatory updates and changes, ensuring the team and company remain informed and compliant with evolving guidelines, and participating in SFDA conferences and workshops to build industry connections and gather insights for the team.

6.Expanded responsibilities to include oversight of the GHC office, managing Gulf registration processes, and ensuring timely follow-up.

7.Leading the ePIL project for KSA and all GHC countries, ensuring successful implementation and compliance across the region.

• Bachelor’s degree in Pharmacy, Life Sciences, Regulatory Affairs, or a related scientific discipline from a recognized university.
• 5–7 years of relevant experience in Regulatory Affairs within the pharmaceutical, medical device, healthcare, or related life sciences industry, with demonstrated experience in the Saudi/GCC regulatory environment.
• Proven experience in preparing, reviewing, submitting, and maintaining regulatory dossiers and product registration/renewal files, preferably with direct experience with SFDA requirements.
• Experience in GCC regulatory submissions and registrations, including coordination with regional offices and regulatory authorities.
• Previous experience in a supervisory or senior Regulatory Affairs role, with the ability to coordinate team activities, prioritize workloads, and ensure timely delivery of regulatory commitments.
• Experience managing cross-functional and external stakeholder relationships, including communication with regulatory authorities, consultants, distributors, and internal departments.
• Demonstrated experience in regulatory systems, RIM/electronic submission platforms, or other regulatory digital transformation projects, with experience acting as a system superuser or key user preferred.
• Strong knowledge of Saudi and GCC regulatory guidelines, with the ability to monitor regulatory changes and assess their impact on the business.
• Experience leading or contributing to regional regulatory projects, such as ePIL implementation, process optimization, system implementation, or harmonization initiatives.
• Strong project management, communication, problem-solving, and organizational skills, with the ability to manage multiple priorities and meet strict regulatory timelines.

Preferred candidate

Years of experience

No experience required

Degree

Bachelor's degree / higher diploma