Regulatory Affairs Specialist (Saudi Arabia)
Location: Riyadh, Saudi Arabia (Hybrid 3 days onsite, 2 days remote)
Contract: Full-Time, 12-Month Fixed-Term Contract
Start Date: March (subject to notice period)
About the Opportunity:
Ready to take your regulatory expertise to the next level Kelly FSP is partnering with a leading global pharmaceutical organization recognized for its strong legacy in innovation, scientific excellence, and commitment to improving patient outcomes worldwide. With operations across multiple therapeutic areas and a robust pipeline spanning pharmaceuticals and medical devices, this organization plays a critical role in advancing healthcare solutions across emerging and established markets.
As a Regulatory Affairs Specialist, you will support regulatory activities across the EMEA region, with a strong focus on collaboration with the Saudi Arabia office. This role is ideal for a regulatory professional who enjoys working cross-functionally, strengthening internal partnerships, and supporting compliance activities without direct health authority interaction or hands-on dossier preparation.
Role Overview:
The Regulatory Affairs Specialist will provide regulatory support to assigned products and projects, both new and existing, ensuring alignment with global and regional regulatory requirements. The role involves coordination, documentation oversight, regulatory intelligence support, and internal stakeholder engagement, while acting as a key regulatory contact for local business partners.
This position does not require direct engagement with the Saudi Health Authority and does not involve preparation of regulatory submission documents.
Key Responsibilities:
- Ensure compliance with applicable regulatory agency regulations, guidelines, and internal interpretations
- Support responses to regulatory agency questions and internal correspondence, as required
- Organize and maintain regulatory reporting schedules related to new drug applications (NDAs) and investigational new drug applications (INDs)
- Prepare regulatory outputs including outlines, summaries, status reports, memos, presentations, tables, and tracking tools
- Review and approve promotional and non-promotional materials in compliance with corporate and governmental requirements
- Provide regulatory guidance and support to local business partners and internal stakeholders
- Liaise effectively with regional and global Regulatory Affairs teams to ensure alignment
- Conduct searches of existing regulatory records and archives to retrieve requested information
- Maintain, organize, and archive regulatory documentation in accordance with internal standards
- Support regulatory intelligence activities, including tracking competitor regulatory activities and market trends
Functional & Technical Competencies:
Must Haves
- Minimum 2 years of Regulatory Affairs experience within the pharmaceutical and/or medical device industry
- Working knowledge of FDA regulations and CE Marking requirements
- Proficiency in MS Office applications (Word, Excel, PowerPoint)
- Strong written and verbal communication skills
- Fluency in English and Arabic (both required)
- Strong organizational and coordination skills
- Ability to work independently and collaboratively in a hybrid environment
Nice to Haves
- Experience supporting EMEA or Middle East regulatory operations
- Exposure to global or matrixed regulatory organizations
- Project coordination or project management experience
- Experience reviewing promotional materials for compliance
Leadership & Behavioral Competencies
- Demonstrates effective collaboration and influence through strong partnerships
- Persists in the face of challenges and adapts to changing priorities
- Listens actively and understands stakeholder motivations, needs, and perspectives
- Manages assigned regulatory activities independently or with limited supervision
- Contributes to competitive intelligence by researching and reporting on regulatory activities of competitors
Education & Experience
- Bachelor's degree (B.A./B.S.) in a technical or scientific discipline required
- 25 years of Regulatory Affairs experience, or a Master's degree with equivalent experience
- Proven ability to identify gaps in processes and contribute to practical solutions
Additional Role Details:
- Hybrid working model: 3 days onsite in Riyadh, 2 days remote
- Full-time, 12-month fixed-term contract
- Start date targeted for March, subject to notice periods
- No direct contact with the Saudi Health Authority
- No regulatory document preparation responsibilities
- NonSaudi nationality preferred
- The role prioritizes strong communication skills to enhance collaboration within the Saudi Arabia office
- Applications are welcome from all qualified candidates; the current team has a slight preference toward male candidates due to team balance considerations
