Regulatory Affairs Lead – Algeria & Tunisia (1‑Year Fixed‑Term)

About the role

Takeda is seeking an experienced Regulatory Affairs Lead to head its regulatory activities in Algeria and support operations in Tunisia on a one‑year fixed‑term basis. The role combines strategic leadership with hands‑on management of regulatory submissions, compliance, and product lifecycle activities.

Key responsibilities

• Lead the Regulatory Affairs (RA) team in Algeria and act as a member of the local leadership group.
• Develop and align regulatory strategies with the EAMEA RA head and the GEM RA team.
• Maintain effective communication with local health authorities for all registration and compliance matters.
• Prepare, submit, and negotiate regulatory approvals for Algerian products.
• Collaborate with Global Regulatory Affairs to gather required dossier documents.
• Manage product lifecycle tasks, including registrations, renewals, change control, and safety reporting.
• Assess the impact of new or changing regulations and ensure labeling and promotional material compliance.
• Support the RA Head EAMEA and country managers on specific projects and strategic initiatives.

Required profile

• Pharmacy degree.
• 5‑8 years of regulatory affairs experience, with at least 5 years in a medium to large pharmaceutical organization operating in Algeria.
• Proven leadership and strategic thinking abilities.
• Strong communication skills and ability to work with cross‑functional teams.

Required skills

• Regulatory submission preparation and negotiation.
• Regulatory strategy development.
• Product lifecycle management.
• Understanding of Algerian and Tunisian pharmaceutical regulations.