The Regulatory Affairs Manager is responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements.
- Create and maintain contacts with Ministry of Health and organizations participating in registration, expertise and quality control of medicinal products in Nigeria.
- Monitor registration requirements, quality assurance, product maintenance of medicinal products and inform the Head of Regulatory Affairs and all departments on changes connected with product portfolio promotion and sales.
- Carry out all activities pertaining to registration and maintenance of product portfolio, subsidiaries and company partners as defined by Head of Regulatory Affairs.
- Ensure adherence to industry-specific codes of practice, advertising codes, regulatory directives and guidelines as applicable to the role and Programs for Legal Compliance and Corporate Responsibility of the company.
- Participate in development and implementation of packaging, labelling and application instructions.
- Check conformity of NDA, include relevant corrective amendments and provide the links between Product supply and Regulatory Affairs functions.
- Support projects of business units through review and approval of promotional material; ensure the company promotional material comply with the company and local country requirements.
- Ensure product supply chain compliance as well as the local quality representation.