Regulatory Submission Lead

Position Summary

You will lead planning, compilation, and delivery of regulatory submission dossiers for investigational and lifecycle activities in the United States. You will work closely with global submission teams, clinical, CMC, quality, publishing, and local regulatory partners. You are organized, collaborative, communicate clearly, solve problems practically, and focus on delivering high‑quality submissions on time. This role offers visible impact on patient access, strong growth opportunities, and alignment with GSK’s mission of uniting science, technology, and talent to get ahead of disease together.

• Plan, compile, and deliver complete regulatory submission dossiers (electronic and paper) on agreed timelines.
• Coordinate and track cross‑functional inputs from clinical, CMC, quality, safety, and commercial colleagues.
• Coordinate and manage Certificates of Pharmaceutical Product (CPPs), as well as notarization and legalization activities in support of global submissions.
• Build, validate, and quality‑check electronic submission packages and resolve technical validation issues.
• Maintain submission trackers, version control, and milestone plans to ensure transparency and audit readiness.
• Draft and coordinate responses to regulatory authority questions and support regulatory meetings.
• Identify and implement process improvements, coach colleagues, and share best practices.

• Bachelor’s degree in life sciences, pharmacy, chemistry, regulatory affairs or related discipline, or equivalent experience.
• 3+ years of experience in regulatory affairs, submission management, publishing, or lifecycle maintenance within the pharmaceutical or clinical research environment.
• Experience compiling regulatory dossiers and managing submission timelines for investigational or marketed activities.
• Experience preparing electronic submissions and familiarity with eCTD principles or equivalent electronic submission practices.
• Experience interacting with Health Authorities, particularly the US FDA.

• Experience with regulatory content or information management systems such as Veeva Vault or similar platforms.
• Experience with CMC content and Module 1 preparation for submissions.
• Knowledge of CPP processes and legalization/notarization requirements.
• Experience preparing responses to authority questions and supporting regulatory meetings.
• Experience working in a global, matrix environment and coordinating third‑party vendors.
• Prior experience leading small project teams or serving as single point of contact for submissions.
• Professional certification in regulatory affairs or related field.
• Proven ability to manage third‑party vendors and external partners.
• Strong written and verbal communication skills with the ability to present clear stakeholder updates.
• Strong organizational skills, attention to detail, and proven ability to manage competing priorities under deadlines.
• Strong compliance mindset with high attention to detail.
• Experience working in a global, matrixed environment, interpreting complex regulatory requirements.
• Good digital proficiency.

This position is hybrid in the United States. Expect a mix of in‑office days for team collaboration and remote days for focused work, as agreed with your manager.

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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.