Regulatory Affairs Associate

job Purpose:

Evaluation, preparation, coordination &submission of regulatory documents in compliance with local regulations

• Ensure regulatory compliance, timely submissions & secure regulatory approval in GNE markets.
• Managing all the internal processes between GNE-RA and the central team.
• Enable the company to achieve its objectives by obtaining marketing authorization approvals/ license maintenance on time.
• Strategic planning for life cycle maintenance.
• Liaising with different functional departments at the start of the project to provide early and broad visibility to upcoming projects for awareness, input and alignment.
• Communication and maintenance of product registration to ensure alignment with all stakeholders.

Core Responsibilities:

• Liaising with different functional departments at the start of the project to provide early and broad visibility to upcoming projects for awareness, input and alignment.
• Ensuring proper communication of all WIP by updating eForms.
• Responsible for completion of regulatory files for submission. (Prepare/Receive files and submit them to regulatory authorities within the defined and agreed submission/approval dates) and according to guidelines and requirements.
• Manufacturing site registration and license maintenance.
• Responsible for coordinating the MSRs to ensure right first time dossiers are provided.
• Coordinate and respond o the requests by authorities during the evaluation process and check the correct handling of deficiency letter within a specific timeframe in order not to delay MOH approvals.
• Establish effective communication and continuous follow-up with the external agencies & distributors to ensure timely submissions and approvals of all company’s applications.
• Continuous monitoring of any changes on the existing rules or any new regulations.
• Providing artwork creation support to all GNE Markets, through using the supportive documents & complying with the company SOPs & local guidelines in a timely manner.
• Follow up to ensure that the locally manufactured/packaged artwork (if applicable) is compliant with the latest label updates.
• Authorize approval of technical changes in artwork/ GEXP updates.
• Responsible for follow up with translation providers for timely provision of Arabic text to be incorporated to Local leaflets.
• Announcement of regulatory approvals to all concerned stakeholders.
• Maintenance of all lifecycle activities/ Product Detail Set in OPAL by accurately updating all submissions and approval within the preset global timelines.
• Renewal event creation for active licenses for the respective GNE Markets
• Review of regulatory information enclosed in technical terms of supply prepared by QA.
• Ensure alignment of regulatory objectives with GNE strategies, regional / global regulatory objectives and commercial plans.

Scope:

Market authorisation approvals and lifecycle maintenance activities in Gulf and Near East Markets (UAE, Kuwait, Qatar, Bahrain, Oman, Jordan, Lebanon, Syria & Iraq)

Accountability:

• Timely submissions and approvals of all regulatory dossiers, to ensure supply compliance with the registration details.
• Building professional relationships with all stakeholders internally and externally
• Accountable for ensuring implementation of in scope GSK Global and Local SOPs, policies and procedures in all activities and tasks.
• Accountable for maintenance of all lifecycle activities in the regulatory eForms database and OPAL.
• Identifying all potential risks and update to all relevant stakeholders.
• Complying to local authority guidelines
• Accountable for ensuring labeling compliance to the latest labeling information.