Regulatory Affairs Executive at GlaxoSmithKline Plc (GSK)

Job Purpose

As a Regulatory Affairs Executive, you will be responsible for adding value to the business by ensuring timely submissions and approvals for new products in West Central Africa (FWCA) markets as well as maintenance of registered licenses in alignment with local regulations and corporate policies. You will also support the WCA Regulatory Affairs strategies, SOP and Training activities in FWCA

Essential Job Responsibilities:

• Ensure timely submissions and approvals of applications according to regulatory plan and strategy, ensuring continuity of supply and regulatory compliance.
• Work effectively with key stakeholders and 3rd party service providers.to achieve the desired regulatory outcomes
• Liaise with Regulatory Authorities and provide appropriate answers on matters relating to Regulatory approvals/queries for GSK Products.
• Ensure alignment of registered details with original dossiers and corporate databases, maintenance of and compliance with Regulatory Databases (Veeva Vault, REQUIRE)
• Support the artwork control process to ensure changes and approval are done in time to avoid product stock out or delays in supplies.
•  Management of tender activities in relevant markets (as applicable)
• Monitor and keep in touch with changes in the regulatory environments. Provide intelligence to local operating company stakeholders and central team on changes in regulatory environment in the region
• Support the QMS/QRM processes within Regulatory (written standard maintenance/compliance, regulatory issue management, risk management, management monitoring (L1 Audit), deviation handling, CAPA management, training, 3P oversight)

Basic Qualifications:

• Life Science Qualification
• Minimum of 1 to 2 years Regulatory Experience in the industry
• Good working knowledge of regulations, current industry practices, and experience with seeking out, interpretation and application of regulatory guidance.

Preferred Qualifications:

• Excellent communication and negotiation skills
• Masters or PhD (would be an added advantage)
• Qualification in project management (would be an added advantage)