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Regulatory Affairs Officer (Biovaccines) at May & Baker

by Sammy
vacancy

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

How to Apply

Interested candidates should send their CV to careers@may-baker.com

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