Regulatory Affairs Officer (Biovaccines) at May & Baker

Responsibilities

• Reporting to the Chief Operating Officer, The Regulatory Affairs Officer will be responsible for all external and internal regulatory compliance for the business.
• Ensure that all Regulatory Certifications and Operational Permits and Licenses for the Premises, Warehouse and Superintendent Pharmacist are in place.
• Achieve all product Marketing Authorization filing and prompt renewal for both locally manufactured and imported vaccines, as well as for 3rd Party products.
• Ensure that all product and manufacturing process variations are promptly filed, and approvals obtained from NAFDAC.
• Obtain import permits, endorsements, and prompt removal of hold labels for imported products.
• Achieve zero incidences of Non-Compliance and Non-Conformance that may lead to fines and penalties.
• Maintain an updated register of relevant KOL at the respective Regulatory Institutions.
• Any other relevant duties as may be communicated from time to time

Qualifications

• B. Pharm (preferred)/B.Sc. Biological Sciences (Microbiology, Biochemistry) with at least 2 years in a similar role.

Role Expectations:

• Leadership; Team player; Effective communication; A high level of organisation, record keeping, attention to detail, and orderliness; Proficiency in computer applications including