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 chance 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 Why you Qualifications We are looking for professionals with these required skills to achieve our goals Degree in a biological healthcare or scientific discipline or Extensive experience in the Regulatory Affairs area Understanding of the pharmaceutical industry R D processes and objectives A

📌 Regulatory Specialist, Submission Coordination; Sde, Lcm (Bengaluru)
🏢 Glaxosmithkline
📍 Bengaluru