Legal & Compliance Manager

The Legal & Compliance Manager will be responsible for overseeing all legal and regulatory affairs, ensuring adherence to pharmaceutical compliance standards, managing corporate governance, handling contractual agreements, and overseeing litigation. The role requires expertise in regulatory compliance, particularly within the healthcare sector, and involves advising the board on legal matters and risk management.

1. Handle all aspects of Pharmacy & Poisons Board (PPB) licensing, including retention, GMP compliance, premises, manufacturing, and import/export licenses.
2. Liaise with regulatory bodies such as PPB, KEBs, NEMA, and KRA Customs.
3. Provide legal advice on WHO-GMP, USFDA, and EMA documentation from a legal standpoint.
4. Manage product registration dossiers, intellectual property, and trademarks for brands.
5. Support company secretarial duties, including preparing board papers, resolutions, and annual returns at the Registrar of Companies.
6. Maintain statutory registers, shareholding records, CR12s, and the compliance calendar.
7. Advise the board on the Companies Act 2015, corporate governance, and risk.
8. Draft, review, and negotiate various contracts, including distributor agreements, supplier/SRMAs, loan documents, lease agreements, NDAs, and employment contracts.
9. Manage vendor claims, debt recovery, and distributor defaults.
10. Handle labor law matters, including disciplinary hearings and HR legal issues.
11. Oversee external legal counsel and work to reduce legal expenditure.
12. Represent the company in disputes, KRA tribunals, and PPB matters.
13. Maintain a litigation tracker and provide financial provisions advice.
14. Develop and implement a compliance framework, including SOPs, a code of conduct, anti-bribery policies, and data protection measures (ODPC Act).
15. Establish a whistleblower policy and conduct staff training on regulatory changes.

1. Bachelor of Laws (LLB) or Master of Laws (LLM) degree.
2. Certifications in Regulatory Compliance, with a preference for exposure in the healthcare industry.
3. 3-6 years of relevant experience.