Reg Submission Lead, SDE- LCM

Job Summary

The Regulatory Submission Lead is responsible for independently supporting regulatory submission activities, including authoring, reviewing, providing Regulatory registration requirements and compiling dossiers for assigned deliverables in compliance with health authority regulations and GSK policies and processes. The position holder works with the Submission teams, Local Operating Company contacts, Global Regulatory Strategy or Functional Teams (or equivalent) to coordinate and prepare submission packages within the Veeva Vault system.

The position holder will also include mentoring and training new team members.

Responsibilities

• Responsible for independently delivering assigned submissions as per 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 in assigned markets.
• Simultaneously oversees, multiple project assignments, including Variations (CMC and Therapeutic), PBRER, Renewals, Site Registrations/Site Renewals, Tenders of more complexity.
• Manage complex 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.
• Independently prepare, coordinate and ensure timely delivery of documents requested from health authorities, legalisation providers, manufacturing sites or third parties.
• Collaborates with staff across various functions and demonstrates the ability to engage with senior-level process development teams by providing advice, interpreting relevant guidelines, conducting research, and resolving complex issues. Possesses comprehensive knowledge of GSK processes and workflows, offering training, consultation, and tailored solutions both within and beyond the department.
• Ensure alignment with a comprehensive understanding of regulatory requirements, legislation, and guidelines for EU, US, and ROW markets, including Regulatory registration requirements. Independently perform data assessments to confirm that the dossier meets all necessary standards and is fit for purpose.
• Responsible for conducting scenario planning for multiple regulatory strategies and recommending delivery approaches to support accelerated timelines when needed. Proactively escalates business-impacting issues and suggests potential solutions.
• Serve as a reviewer for peers deliverables and propose improvements to regulatory processes, policies, and systems, thereby driving efficiency innovation.
• Engage with Regulatory Agencies to address and resolve issues within their areas of responsibility.
• Demonstrates a strong understanding of regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global applications.
• 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.

Qualifications

• Bachelor's degree or higher in biological or healthcare science.
• Preferably 5 years of experience with a strong understanding of industry, drug development, and RD processes.
• In-depth knowledge of regulations, guidelines, and policies for pharmaceutical and vaccine registration and manufacturing.
• Proficient in using Veeva Vault systems to ensure efficient and compliant submission deliverables.
• Excellent organizational, communication, and interpersonal skills, with a focus on delivering high-quality results under tight deadlines.
• Skilled in interpreting global regulatory requirements and providing expert guidance based on recent GSK experience.
• Adaptable and proactive in managing workloads, priorities, and timelines while effectively collaborating in a matrix environment.
• Proven ability to handle multiple projects simultaneously and build strong relationships with internal stakeholders.