This is a hands‑on leadership role overseeing all regulatory activities in Saudi Arabia, including registrations, renewals, pricing, lifecycle management and upcoming launches. The position combines strategic influence with operational responsibility and serves as the primary point of contact with the SFDA and other key authorities.

Client Details

Our client is a leading global pharmaceutical organisation with a diverse and growing portfolio spanning established medicines, innovative therapies and rare disease assets. The company is recognised for its scientific excellence, strong pipeline, and commitment to advancing patient outcomes across the Middle East region.

Description

The Head of Regulatory Affairs - KSA will lead the country's regulatory function, ensuring full compliance, timely submissions, and alignment with local, regional and global priorities. This role builds and leads the KSA regulatory team while acting as a key member of the country leadership team and a strategic partner to commercial, medical, quality and supply chain functions.



Key responsibilities include:
Build, lead and develop the KSA regulatory team to meet current and future objectives, ensuring strong alignment with local, regional and global regulatory and commercial priorities.Serve as a key member of the country leadership team with continuous alignment to the GM.Develop and execute the regulatory strategy for Saudi Arabia, ensuring full lifecycle management across the portfolio.Contribute to cluster and global strategy development by providing country‑specific insights, product data, and regulatory intelligence.Identify, prioritize and resolve technical, operational and organizational issues of medium to high complexity.Filter, analyse and validate information from multiple internal and external sources to support decision‑making and mitigate regulatory challenges.Adapt operational plans and priorities to respond to evolving regulatory requirements and resource needs.Act as the primary face of the company with SFDA and other relevant authorities (GHC, RPCC, SAIP, SNIH, agents, vendors).Develop and maintain strong, credible relationships with regulatory and industry bodies to influence legislation, shape the external environment, and secure optimal regulatory outcomes.Lead negotiations related to pricing and economic evaluations (EES) in collaboration with Market Access.Ensure full compliance with global, regional and local regulatory, statutory and quality requirements.Stay up to date with evolving regulations and ensure organisational readiness.Participate in all required GDP trainings and maintain audit readiness.Partner closely with Commercial, Supply Network Operations, Quality, Pharmacovigilance , Manufacturing Sites, Medical Affairs and Global Regulatory Affairs.Ensure effective coordination between regulatory strategy and broader business objectives.Develop and manage the departmental budget, including personnel and local commercial spend.Contribute to resource planning, policy development and workforce capability planning.




Profile

We are seeking a Saudi national with strong hands‑on regulatory expertise and the leadership maturity to influence both internal and external stakeholders. Ideal candidates will bring:
8-10+ years of regulatory affairs experience, preferably at Senior Manager or Associate Director level, with readiness to step into a country head role.Deep practical understanding of the KSA regulatory landscape and SFDA processes, evidenced by real‑life achievements.Strong relationships with SFDA and, ideally, direct interactions with Heads of Departments.Expertise in pricing, economic evaluation studies (EES) and negotiations with authorities.Experience with innovative assets, including ODD, breakthrough, verification or abridged pathways (a strong plus).Cross‑functional agility across RA, quality, supply chain, pharmacovigilance and market access.High planning discipline, accountability and problem‑solving capability.Ability to lead, develop and motivate team members.




Job Offer
A senior leadership mandate with both strategic and operational influence.Career progression within a global, science‑driven organisation.Competitive compensation and benefits.

Skills

regulatory affairs, KSA, rare disease