Background

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare - a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the worl...

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
• 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.

• 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.

• Education: Minimum of a Bachelor of Pharmacy (B.Pharm) degree.
• Professional Registration: Valid registration with the Pharmacy and Poisons Board (PPB), Kenya.