Regulatory Affairs Officer
| Location | Nairobi, Kenya |
| Date Posted | October 16, 2022 |
| Category |
Administration
|
| Job Type |
Full-time
|
| Currency | KES |
Description
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 world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims for improving patient access to medical innovations by working with all relevant stakeholders. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology; Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
Key Responsibilities:
Filings:
- Ensure regulatory filings are aligned with commercial and supply needs to assure business continuity.
- Interact and negotiate with local HAs and internal stakeholders to build and cultivate trusted partnerships.
- Influence internal and external stakeholders for successful regulatory outcomes.
Regulatory Compliance:
- Maintain current knowledge of international and local regulations and other governing regulatory practices, policies, procedures, processes, systems and standards.
- Support regulatory inspection-readiness for the Affiliate, including participating in internal/external regulatory audits.
- Ensure affiliate regulatory activities comply with Roche global standards and local regulations.
Strategy/Planning:
- Contribute to Local regulatory strategies, considering local regulation and business needs.
- As assigned, gather and disseminate regulatory intelligence within the Affiliate; involving regional and global organisations, when appropriate.
- Participate in industry associations on regulatory policy and regulations.
- Provide Regulatory Affairs input into relevant cross-functional Affiliate business strategies (e.g. market access, medical affairs, promotional activities, public policy etc.).
- Develop innovative, risk-based regulatory strategies and workplans for assigned products or business areas within the Affiliate to accelerate access .
Other:
- Manage relevant Affiliate regulatory activities on applicable Roche systems to ensure appropriate, thorough and timely regulatory information and document management.
- Where applicable, manage end-to-end local product packaging and labelling from a regulatory perspective.
- Where applicable, review and approve promotional materials to provide regulatory input and guidance to other Affiliate functions and teams.
- As applicable, supervise and manage shipment clearance of Affiliate materials/products .
You, as an ideal candidate, will have the following skills, experience and education:
- Essential: University Degree in Pharmacy and Practicing License is mandatory.
- Experience: At least 2-5 experience in a Regulatory Affairs role.
- Other requirements: Fluency in written and spoken English.
Job Level: Individual contributor.