Regulatory Affairs Associate | Fixed-term contract

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 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.

• 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. • 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 • 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. • 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.