Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. 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).
Main 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
Interested and qualified candidates should apply online by visiting the official careers application link: Roche Kenya on careers.roche.com.
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