Regulatory Specialist, Submission Coordination works closely with global submission teams, Local Operating Company regulatory contacts) to deliver end-to-end submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices.

This role offers an excellent opportunity to develop your expertise in Regulatory Affairs while collaborating with cross-functional teams and gaining exposure to global submission processes.

Basic Qualification -


 

• Responsible to deliver marketing applications and lifecycle maintenance submissions including activities such as product renewals, site submissions, variations within agreed timelines, in compliance with Regulatory Authority regulations and guidelines, GSK SOPs, and working practices, and in collaboration with relevant submission teams as needed.
• Coordinate MSR for various types of submission, independently and confidently executing agreed dossier strategy. Assist in scenario planning when multiple regulatory strategies are considered.
• Identify and escalate risks associated with submission delivery that have business impact.
• Understand and apply regulations, guidelines, procedures, and policies relating to the registration and manufacturing of pharmaceutical products to expedite submission delivery. delivery.
• Participating in process improvement initiatives, as required
• Participate as needed in submission teams to support product regulatory authority submissions or maintenance activities for approved products, including product renewals, site registrations/renewals/variations, and periodic benefit risk evaluation report (PBRER) submissions.
• Mentoring/training of other team members as required.