Regulatory Affairs Manager – Saudi Arabia

About the role

Takeda is seeking a Regulatory Affairs Manager to lead product registration and lifecycle management activities in Saudi Arabia. You will work closely with international RA strategists and local business partners to ensure compliance with Saudi health authority requirements.

Key responsibilities

• Develop and implement regulatory strategies for Takeda’s products in collaboration with global teams.
• Prepare and submit applications, variations, and post‑approval reports to the Saudi Food and Drug Authority (SFDA).
• Assess local business and regulatory requirements for investigational and marketed products and produce assessment reports.
• Maintain up‑to‑date knowledge of Saudi regulatory changes and advise internal stakeholders.
• Coordinate with local distributors, conduct site visits, and manage the final submission process on the SFDA platform.
• Negotiate product pricing with the SFDA and oversee the receipt, archiving, and renewal of registration certificates.

Required profile

• Bachelor’s degree in pharmacy from a recognized university.
• Minimum 5 years of experience in regulatory affairs, including at least 3 years in a medium‑to‑large pharmaceutical organization.
• Strong understanding of SFDA regulatory pathways and the Saudi pharmaceutical market.
• Ability to work in a fast‑paced environment and manage competing priorities.
• Excellent verbal and written communication skills in English.

Required skills

• SFDA submission platform proficiency
• HPLC column handling and related laboratory ordering
• Regulatory affairs expertise in pharmaceutical products