Production / Regulatory Pharmacist at Lorache Consulting Limited

Responsibilities

• Interaction and coordination with pharmacy practice and regulatory bodies / agencies(SON, NAFDAC, PCN, etc)
• Ensuring that regulatory requirements are complied with to the satisfaction of the relevant agencies.
• Guiding company to comply with regulatory requirements.
• Participating in advocacy and public corporate responsibility
• Make sure clear lines of accountability exist and that retrievable audit trails for documentation relating to the operation of the company are kept.
• Development and registration of imported formulations and other pharmaceutical products.
• Regular warehouse inspection.
• Coordination of import of finished formulations, active pharmaceutical ingredients (APIs), and other medical / pharmaceutical products.
• Registration of premises for distribution and wholesale when required.
• Handle compliance issues relating to the import and registration of imported products.
• Monitoring continuous improvement of good Manufacturing Practices on the process by process basis.
• Responsible for the authorization of manufacturing process, releasing, and delivery of finished goods.
• Responsible for registering the company premises and carries out regulation as contained in chapter 152 of the pharmacy law.

Requirements

• Pharmacy Degree, an (MSc) may be an advantage but is not essential.
• Minimum of 5 years’ appropriate Regulatory Experience.
• Knowledge of the Local regulatory environment and how this impacts regulatory strategy and implementation.
• Knowledge of drug development practice, rules, regulations, and guidelines.
• Communication skills.
• Negotiation skills.
• Understands Pharmaceutical Industry.