Regulatory Affairs Associate | Fixed-term contract at Roche Kenya

Roche Kenya is seeking a Regulatory Affairs Associate on a fixed-term contract in Nairobi to support regulatory submissions and post-marketing compliance for Roche’s East Africa affiliate.

What it offers

• Fixed-term contract role in Nairobi, Kenya
• Focus on regulatory submissions, post-marketing variations, safety updates, and renewals

Who can apply

• Minimum education: Bachelor of Pharmacy (B.Pharm) degree
• Professional registration: Valid registration with the Pharmacy and Poisons Board (PPB), Kenya
• Experience: 2 to 3 years of regulatory affairs experience in a multinational pharmaceutical or life sciences organization
• Core skills: Autonomy, attention to detail, agility, prioritization, communication, solution-oriented mindset, and integrity

What you'll do

• Execute affiliate regulatory strategy and align product registrations with business timelines
• Prepare, review, and submit regulatory applications to local health authorities
• Manage post-approval lifecycle activities, including variations, safety labeling updates, GMP renewals, and registration renewals
• Maintain real-time accuracy in Roche’s Global Regulatory Information Management Systems (RIMS)
• Monitor local regulatory landscape and communicate updates to stakeholders
• Act as backup Qualified Person for Pharmacovigilance
• Collaborate across departments (Medical, Commercial, PV, Quality) to support business continuity
• Engage with health authorities and industry bodies

How to apply

• Visit careers.roche.com to apply
• Build and download your CV for free using available templates