Regulatory Affairs Executive at GlaxoSmithKline

Requisition ID: 311614
Location: Ilupeju, Lagos
Employment Type: Full Time
Categories: Regulatory

Job Purpose

• As a Regulatory Affairs Executive, you will be responsible for the Licensing of Pharmaceutical products and Vaccines from GSK and GSK- owned entities and processing of related approvals with relevant Regulatory Authorities

Essential Job Responsibilities

• Managing product license life cycles for GSK assets including Pharmaceuticals, Vaccines and other government regulated products.
• Managing Pharmaceutical Premises and Pharmacists Annual Licensures.
• Processing of Regulatory Intelligence and continuous value-adding to relevant regulatory databases.
• Maintenance of Inventory register for all controlled products
• Co-ordination of destruction exercises within the company and between the company and the regulatory authority for all Pharmaceuticals and vaccines.
• Participation in projects
• Maintenance of Regulatory Affairs Business Partnerships with customers and stakeholders (Commercial, Medical Quality, Legal teams) & effective coordination with  other identified stakeholders to implement new developments or changes to products or processes.
• Implementing all GSK regulatory expectations and timely delivering on our Purpose.

Why you?
Basic Qualifications:

• Pharmacy Degree
• Minimum of 3 years Regulatory Affairs experience (in similar environments), post Licensure with the Pharmacists Council of Nigeria (PCN).

Preferred Qualifications:

• Good Communication skills.
• Possess sound understanding of basic Regulatory guidelines both locally and internationally.
• Have excellent engagement skills (Will need to work with Government Regulators)
• Be Computer Literate and proficient
• Must constantly search for Innovations
• Excellent knowledge of Quality Management Systems and principles  especially as applicable to Regulatory Affairs
• Need to be able to adapt quickly to constantly changing regulatory policies and environment.
• Be capable of Quick adaptation to continuously increasing responsibilities.
• Must be resilient and excellent at managing work pressures and be capable of planned and organised work.