Regulatory Affairs Specialist KSA

Company: Galderma –

WebSite: Riyadh, Saudi Arabia

Job Description:**Formal Restructuring of the Text:**

Galderma, a prominent and rapidly expanding entity exclusively dedicated to dermatology, maintains a presence in approximately 90 countries. The organization offers a science-backed and innovative portfolio of premium flagship brands and services, addressing the complete spectrum of the burgeoning dermatology market through Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Since its establishment in 1981, Galderma has focused on the human skin, addressing the diverse needs of both consumers and patients through superior solutions provided in collaboration with healthcare professionals. Recognizing the profound impact of skin health on individual lives, Galderma is dedicated to advancing dermatological solutions for all.

Galderma seeks individuals who demonstrate a results-oriented approach, embrace continuous learning, and contribute positively to the work environment. Ideal candidates should exhibit initiative, foster teamwork, and collaborate effectively. A paramount requirement is a demonstrated passion for delivering meaningful solutions to consumers, patients, and healthcare professionals. The organization aims to empower employees, promote individual development, and ensure the ongoing fulfillment of business objectives. Galderma embraces diversity and upholds the dignity, privacy, and personal rights of all employees.

Galderma fosters a culture of belief in its ambitious goal of becoming the world’s leading dermatology company. The organization provides unparalleled opportunities for employees to acquire challenging new experiences and make a significant, direct impact.

**Regulatory Affairs Specialist – Kingdom of Saudi Arabia**

**Location:** Riyadh, Kingdom of Saudi Arabia

**Job Description:**

The Regulatory Affairs (RA) Specialist will be responsible for executing local regulatory activities to maintain and ensure the compliance of the RA portfolio in the Kingdom of Saudi Arabia (70% of responsibilities) and the United Arab Emirates (30% of responsibilities). The RA Specialist will support the RA Manager in operational RA submissions and in ensuring continuous compliance with all RA and Standard Operating Procedure (SOP) responsibilities. The incumbent must maintain audit readiness at all times for inspections by Health Authorities (HA). The RA Specialist will ensure business continuity, acting as a backup for the RA Manager in the KSA and for Quality Assurance (QA) and Pharmacovigilance (PV) functions. Considering that RA, QA, and PV are essential functions requiring continuous on-site availability, including during vacation periods, the presence of at least one representative from RA, QA, or PV is required at all times.

The RA Specialist will provide strategic and operational RA support for Saudi Arabia, ensuring the timely renewal, maintenance, and variation of existing and new products, including prescription medications, injectable aesthetics, medical devices, and cosmetics. It is critical to maintain momentum to ensure compliance with constantly evolving Saudi Food and Drug Authority (SFDA) guidelines.

**Duties and Responsibilities:**

* Manage the entire registration process, ensuring approvals for new products and amendments to existing products.
* Develop and execute registration strategies in close collaboration with Global RA and the local RA Manager.
* Remain current with and ensure compliance with the continuously evolving (complex and country-specific) regulatory frameworks in the Kingdom of Saudi Arabia and the United Arab Emirates.
* Ensure compliance with and maintenance of existing product licenses.
* Ensure high-quality and timely submissions; support in enhancing regulatory intelligence; and create and maintain databases to streamline local RA processes for record retention and regulatory submission tracking.
* Ensure that progress on 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.
* Provide critical support to ensure ongoing RA compliance and serve as a backup for RA, QA, and PV functions.
* Support projects that require process enhancements and simplification tools for all Middle East markets, such as tracking tools and data management.
* Internalize certain RA activities currently outsourced, such as electronic Common Technical Document (eCTD) preparation, in a phased manner.

**Minimum Requirements:**

* Pharmacist degree or Bachelor’s degree in Pharmaceutical Sciences.
* Saudi Arabian national and Ministry of Health (MOH) licensed pharmacist.
* Minimum of 4-5 years of experience in a similar Regulatory Affairs role in the field of prescription medicinal products and medical devices in Saudi Arabia and the United Arab Emirates.
* In-depth understanding of the pharmaceutical industry within Saudi Arabia and strong connections with the SFDA are preferred.
* Experience in Quality Assurance and a working knowledge of Pharmacovigilance are preferred.
* Computer literate, familiar with electronic documentation systems.
* Fluency in written and verbal English and Arabic.

**Benefits:**

Galderma provides an inclusive work environment and believes diversity enriches perspectives and outcomes. The organization offers a competitive compensation package with a bonus structure and an extended benefits package. New employees will join a growing organization that values ownership and empowers individuals to grow and take accountability.

**Application Process:**

Please submit a CV in English. Qualified candidates will be contacted for a virtual interview with a recruiter, followed by a virtual interview with the hiring manager, and a final panel interview with the extended team.

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