Apprentice – Submission Delivery Excellence, LCM (GSK)

Roles and Responsibilities

Key Responsibilities

• Under management oversight, responsible for delivering assigned submissions in line with the agreed dossier strategy to the Submission teams, Local Operating Company contacts, Global Regulatory Strategy or Functional Teams (or equivalent) by working collaboratively with functional teams (e.g., CMC, Clinical, Nonclinical, etc.) & ensuring adherence to established timelines.

• Simultaneously, follow-up for multiple project assignments, including Variations (CMC and Therapeutic), PBRER, Renewals, Site Registrations/Site Renewals, Tenders of varying complexity.

• Manage regulatory registration requirements, including those requested directly from regulatory agencies, manufacturing sites or third-party service providers. This includes providing manufacturing site support to meet regulatory expectations.

• Prepare, coordinate and ensure timely delivery of documents requested from health authorities, legalization providers, manufacturing sites or third parties.

• Accountable for adhering to GSK ways of working, processes and written standards, while building a thorough understanding to ensure right first-time delivery. Leverages regulatory intelligence resources to determine Regulatory registration requirements, ensuring they are fit for purpose for assigned submissions as needed, and proactively identifies risks associated with submission data and information packages.

• Keep regular communication with the line manager, technical lead, functional teams and LOCs (or equivalent), and, where applicable, with health authorities and external stakeholders (certificates and samples). Implements the agreed dossier strategy for assigned deliverables and escalates any issues that could affect the business, such as unavailable deliverables or changes in local requirements.

• Ensures the quality and compliance of both personal and team submissions with regulatory guidelines and processes, under management oversight. May review peers deliverables and propose improvements to regulatory processes, policies, and systems thereby driving efficiency & innovation.

• Develops expertise in regulations, guidelines, procedures, and policies governing pharmaceutical product registration and manufacturing to facilitate efficient submission, review, and approval of global regulatory applications. Demonstrates adaptability and learning agility to navigate internal and external regulatory landscapes.

• Demonstrates strong collaboration skills and the ability to build effective organizational networks, actively fostering and expanding connections within the organization. • Communicate effectively with internal and external GSK stakeholders on project- and policy-related matters with minimal managerial supervision, ensuring the best outcomes for the organization.