Regulatory Affairs Specialist KSA

Galderma; Riyadh; On-site; USD 60,000 - 80,000; Full time

Job summary

A leading company in the pharmaceutical industry seeks a Regulatory Affairs Specialist in Riyadh, responsible for managing compliance and registration processes for medicinal products. The role offers opportunities to enhance strategic regulatory engagement with key stakeholders, ensuring the timely submission and approval of products in line with SFDA guidelines. Candidates should be Saudi national pharmacists with extensive experience in regulatory affairs.

Benefits

Competitive compensation package with bonus structure

Diversity and inclusion workplace

Extended benefits package

Opportunities for growth and accountability

Qualifications

• Minimum 4-5 years experience in regulatory affairs role.
• In-depth understanding of SFDA and pharmaceutical regulations in KSA.
• Quality experience in Pharmacovigilance preferred.

Responsibilities

• Manage the entire registration process for new products.
• Stay compliant with regulatory frameworks in KSA and ME.
• Support RA manager in operational submissions and track regulatory compliance.

Skills

Pharmaceutical Industry Knowledge

Regulatory Compliance

Communication

Project Management

Fluent in English and Arabic

Education

Saudi Arabia national and MOH licensed pharmacist

Tools

Electronic Documentation Systems

Job description

Regulatory Affairs Specialist KSA Galderma

RA Specialist will fulfill the local regulatory activities to maintain & keep the RA portfolio compliant for KSA ( 70 % ) and rest of ME markets ( 30%) . He / she will support RA manager on operational RA submissions to allow the RA managers in UAE & KSA to focus on critical projects Relfydess & Nemluvio . In addition , RA manager in KSA needs to focus on enhancing external engagement with Health authority & local trade association that is identified as a major gap currently. RA Specialist will ensure business continuity and serve as a back up for RA manager in KSA for RA in addition to serving as a back up for QA & PV , considering that RA , QA & PV are mandatory functions to be always available on site .Provide strategic and operational RA support for Saudi to ensure on time renewal, maintenance , variations of existing & new products for IA, TD, DS including mandatory regulatory. It is critical to maintain momentum to ensure compliance to constantly evolving SFDA guidelines

Duties & Responsibilities

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 & country specific) regulatory framework in KSA & rest of ME markets

Ensure compliance with, and maintenance of, existing product licenses.

Ensure high quality and timely submissions, support in enhancing regulatory intelligence , create & maintain database for simplifying local RA processes of record retention , regulatory 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. With the LE set up in Saudi the responsibilities & accountability of RA manager in front of Saudi HA ( SFDA ) have increased requiring more time & focus from RA manager to engage with external stakeholders & ensure compliance at all time for all regulated TD,IA,DS portfolio. RA specialist is critical to ensure compliance to ongoing RA activities , serve as back up for RA / QA/PV and allow RA to focus on critical submissions ongoing & to be made for Relfydess & Nemluvio to enable timely registrations . RA specialist will also support projects that need improvement in process enhancement & simplification tools for all ME markets , such as tracking tools , data management & also internalize some of the RA activities that are currently outsourced such as eCTD preparation in a phased manner

Saudi Arabia national and MOH licensed pharmacist

Minimum 4-5 years experience in a similar Regulatory affairs role in the field of prescription medicinal products and medical devices in Saudi Arabia & UAE

In-depth understanding of the pharmaceutical industry within Saudi Arabia, and strong connections with SFDA will be preferred

Quality experience & fair knowledge of Pharmacovigilance preferred.

Computer literate, familiar with Computer based information systems, and new

Electronic documentation systems.

Fluency in written and verbal English and Arabic

What we offer in return

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.

Next Step

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.

Company Industry

• Pharma
• Biotech
• Clinical Research

Department / Functional Area

• Administration

Keywords

• Regulatory Affairs Specialist KSA

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