Roche
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
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).
Main Responsibilities
1. 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.
2. 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
3. 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.
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.