Regulatory Affairs Associate | Fixed-term contract — Roche
- Location
- Nairobi
- Contract
- full-time
- Posted
- 7 days ago
Role overview
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.
- 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.
- 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.
- & Experience
- Education: Minimum of a Bachelor of Pharmacy (B.Pharm) degree.
Main responsibilities
- 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.
Key requirements
- & Experience
- Education: Minimum of a Bachelor of Pharmacy (B.Pharm) degree.
- Professional Registration: Valid registration with the Pharmacy and Poisons Board (PPB), Kenya.
Application process
- 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.
Company and context
- 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. Who we are A healthier future drives us to innovate.
- Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring ev
Additional details
- Join Roche, where every voice matters. Main Responsibilities Regulatory Submission & Strategy Execution
- Dossier Compilation & Filing: Prepare, review, and submit high-quality regulatory applications to local Health Authorities to secure timely product approvals. Lifecycle Management & Compliance
- Pharmacovigilance: Act as assigned back up Qualified Person for Pharmacovigilance Cross-Functional Partnership & Agility Qualifications & Experience
- 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
- 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.
Notes and original content
- Join Roche, where every voice matters.
- The Position
- Job Purpose
- Main Responsibilities
- Regulatory Submission & Strategy Execution
- Dossier Compilation & Filing: Prepare, review, and submit high-quality regulatory applications to local Health Authorities to secure timely product approvals.
- Lifecycle Management & Compliance
- Pharmacovigilance: Act as assigned back up Qualified Person for Pharmacovigilance
- Cross-Functional Partnership & Agility
- Qualifications & Experience
Questions about this listing
What salary does Roche offer for this role?
Roche lists CHF 62'000 - 94'000 gross per year for this position in Nairobi. This is the salary published in the original listing (or, when the employer omits a figure, a realistic estimate for the role and sector) — the calculator on this site converts it to your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does Roche offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with Roche during the application process, since these details can vary by role even within the same contract category.
Do I need a cross-border work permit for a role in Basel?
EU/EFTA residents living in the border zone of the country adjoining Canton Basel can apply for a G permit; the Swiss employer files it with that canton's migration office after the contract is signed. Border-zone rules and processing times vary by neighbouring country and canton, so confirm the specifics with Basel's cantonal migration office or with HR during the application.
How do I apply for this position at Roche?
Use the "Apply now" button on this page — it links directly to Roche's original listing at roche.wd3.myworkdayjobs.com, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
