Regulatory Submission Lead

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Job Purpose: The Regulatory Submission Lead independently supports regulatory registration requirements, such as Certificates (like but not limited to certificate of Pharmaceutical Product (CPP), Good Manufacturing Practice certificates (GMPc), Seen letters, legalisation and, regulatory samples, …),for submission activities. This includes authoring, reviewing, providing registration requirements and compiling dossiers for assigned deliverables in line 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.

Key Responsibilities:

• Responsible for independently delivering regulatory registration requirements (CPP, GMP, Seen, legalisation, regulatory samples…), for 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.
• 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.
• 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.

Why You? Basic Qualifications:

• Education: Bachelor’s degree or higher in biological or healthcare science.
• Preferably 5 years of experience with a strong understanding of industry, drug development, and R&D processes.
• Excellent organizational, communication, and interpersonal skills, with a focus on delivering high-quality results under tight deadlines.
• 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.
• 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.
• Experience interacting with Health Authorities, particularly Belgium Health authority

Preferred Qualifications:

• In-depth knowledge of regulations, guidelines, and policies for pharmaceutical and vaccine registration and manufacturing.
• Proficient in using digital tools including AI, Veeva Vault systems to ensure efficient and compliant submission deliverables.
• 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.

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