Regulatory Affairs Associate Job Roche

AI summary

Roche Kenya is hiring a Regulatory Affairs Associate to support regulatory submissions and liaise with authorities, ensuring compliance with standards. The role is based in Nairobi and requires a valid PPB registration and a B.Pharm degree with 2-3 years experience in a multinational pharmaceutical environment.

• Full-time, management-level role at Roche Kenya in Nairobi.
• Requires Bachelor of Pharmacy and valid PPB registration.
• 2-3 years regulatory affairs experience in multinational pharma.
• Responsibilities include submissions, lifecycle management, pharmacovigilance.

Description

Home » Jobs In Kenya » Medical Jobs In Kenya » Regulatory Affairs Associate Job Roche Job Title: Regulatory Affairs Associate Date Posted: 16/07/2026 Job Type: Full Time Job Level: Management Employer: Roche Kenya Industry: Medical Salary: Open Location: Nairobi Country: Kenya Deadline: 30/07/2026 Summary: Medical Jobs. Roche Jobs. Looking for a medical and healthcare job in Kenya? Roche Kenya is hiring a Regulatory Affairs Associate to support regulatory submissions and liaise with regulatory authorities to ensure approved medical products meet required standards. The role is based in Nairobi and a valid registration with the PPB is required. Job Purpose The Regulatory Affairs Associate provides critical operational and execution-focused support to the Drug Regulatory Affairs (DRA) Lead. This role is responsible for driving regulatory submissions within the Roche East Africa affiliate. The successful candidate will support the end-to-end lifecycle of post-marketing variations, safety submissions, and renewals, while maintaining real-time data integrity in Roche’s Global Regulatory Information Management Systems (RIMS). Key Responsibilities Regulatory Submission & Strategy Execution Local Plan Management: Collaborate closely with internal stakeholders to execute the affiliate regulatory strategy, ensuring product registrations align with business timelines. Dossier Compilation & Filing: Prepare, review, and submit high-quality regulatory applications to local Health Authorities to secure timely product approvals. Lifecycle Management & Compliance Portfolio Maintenance: Guarantee uninterrupted product supply by proactively managing post-approval lifecycle activities, including variations, safety labeling updates, GMP renewals, and timely registration renewals. Data Integrity & Systems Management: Maintain real-time accuracy in Roche’s Global Regulatory Information Management Systems (RIMS), precisely logging submission and approval metrics to ensure global compliance transparency. Regulatory Intelligence: Continually monitor the local regulatory landscape for shifting guidelines, assess their impact on the portfolio, and communicate updates effectively to local stakeholders and Global Regulatory teams. Pharmacovigilance: Act as assigned back up Qualified Person for Pharmacovigilance Cross-Functional Partnership & Agility Collaborative Liaison: Act as an agile regulatory partner across departments (Medical, Commercial, PV and Quality) to provide regulatory insights that support business continuity. Stakeholder Engagement: Support the DRA Lead in fostering transparent, professional relationships with official health authorities and industry bodies. Qualifications & Experience Education: Minimum of a Bachelor of Pharmacy (B.Pharm) degree. Professional Registration: Valid registration with the Pharmacy and Poisons Board (PPB), Kenya. Experience: 2 to 3 years of hands-on regulatory affairs experience within a multinational pharmaceutical environment or a specialized life sciences organization. Core Skills & Competencies Autonomy & Drive: A highly motivated self-starter with meticulous attention to detail; proven ability to translate general concepts into compliant, successful regulatory outcomes with minimal supervision. Agility & Prioritization: Demonstrated capability to manage multiple complex portfolios simultaneously, dynamically prioritizing tasks to meet strict external and internal deadlines. Communication Excellence: Exceptional written and verbal communication skills in English, with the interpersonal savviness required to navigate health authority networks and cross-functional corporate teams. Solution-Oriented Mindset: Strong analytical skills paired with a collaborative approach to solving compliance challenges in alignment with affiliate objectives. Integrity: High ethical standards and a strict adherence to corporate compliance, local regulations, and industry codes of conduct. How to Apply Click here to apply 🎯 Applying for This Job? Don’t Send a Generic CV. Don’t send the same CV to every job/employer. Have our recruitment team customize your CV to match the requirements of this specific job and improve your chances of getting an interview. Customise My CV For This Job . ⭐ 5-Star Reviews . Job Seeker Testimonials: Professionals Who Got Jobs Through Corporate Staffing Since 2011, Kenyan professionals have trusted Corporate Staffing Services to help them secure employment with leading employers in Kenya and beyond. Read testimonials from candidates who have experienced our recruitment process firsthand and successfully gotten hired through our recruitment services. You Could Be Our Next Success Story . Read How They Got Jobs Through Corporate Staffing GET A JOB FASTER! Applying for a Specific Job? Our recruiters will customise your CV to match the employer's requirements so you can get shortlisted. Customise My CV Used AI to Write Your CV but Not Getting Interviews? Get A FREE CV review and CV Upgr