Regulatory Submission Lead

GSK•Durham, PA

3d•Hybrid

About The Position

This role 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. We value organized, collaborative people who 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.

Requirements

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

Nice To Haves

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 or 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, with the ability to interpret complex regulatory requirements
Good digital proficiency

Responsibilities

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 practice.