Exciting Opportunity for a Regulatory Affairs Executive in GSK
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
Job Type: Full-time
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.
- Pharmacy degree
- Minimum of 3 years Regulatory Affairs experience (in similar environments), post Licensure with the Pharmacists Council of Nigeria (PCN).
- Good communication skills.
- Possess a 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 organized work.
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