Regulatory Submission Lead Role at GSK | Pharmacy Graduates | Apply Online
A rare chance has emerged for professionals in regulatory affairs: GSK is hiring a Regulatory Submission Lead. This full-time position is available in three locations and offers a hybrid work arrangement. Interested candidates are encouraged to apply before the deadline.
About the Company
GSK is a global biopharma company dedicated to uniting science, technology, and talent to combat diseases. With a mission to positively impact the health of 2.5 billion people by the end of the decade, GSK focuses on innovation in specialty medicines and vaccines across therapeutic areas such as respiratory, oncology, and infectious diseases. The company is committed to creating an inclusive environment where employees can thrive and make a significant impact on global health.
- Job ID: 448144
- Category: Regulatory
- Job Type: Full-time
- Posted On: 23 September 2026
- Work Arrangement: Hybrid (Remote & On-site)
Regulatory Submission Lead Job Description
The GSK Regulatory Submission Lead will be responsible for leading the planning, compilation, and delivery of regulatory submission dossiers for lifecycle activities. This role involves coordination with global submission teams, clinical, CMC (Chemistry, Manufacturing and Controls), quality, publishing, and local regulatory partners. The ideal candidate will possess strong organizational skills, attention to detail, and a collaborative approach to problem-solving.
Key Responsibilities
- Plan, compile, and deliver high-quality electronic and paper regulatory dossiers within agreed timelines.
- Coordinate cross-functional inputs from clinical, CMC, quality, safety, and commercial colleagues to complete 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.
- Prepare responses to regulatory authority questions and support regulatory meetings when required.
- Identify and implement process improvements, coach colleagues, and share best practices.
Regulatory Submission Lead Eligibility Criteria
- Bachelor’s degree in life sciences, pharmacy, chemistry, regulatory affairs, or a related discipline, or equivalent experience.
- Minimum 3 years’ experience in regulatory affairs, submission management, publishing, or lifecycle maintenance in the pharmaceutical or clinical research environment.
- Practical 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.
- Strong written and verbal communication skills in English; able to present clear updates to stakeholders.
- Strong organizational skills, attention to detail, and ability to manage competing priorities under deadlines.
Required Skills
- Agile Planning
- Business Acumen
- Change Management
- Digital Fluency
- Learning Agility
- Problem Solving
- Regulatory Strategies
Salary
The annual gross base salary range for new hires in this position is PLN 132,000 to PLN 220,000. This range takes into account various factors, including the candidate’s skills, experience, and education level. Additional benefits may include an annual bonus and eligibility to participate in the share-based long-term incentive program.
How to Apply
Interested candidates are encouraged to apply through the official GSK careers page. For any adjustments during the recruitment process, applicants can reach out to the Recruitment Team at pl.recruitment-adjustments@gsk.com.
Additional Information
GSK is an Equal Opportunity Employer, ensuring all qualified applicants receive equal consideration for employment without regard to race, color, religion, sex, national origin, age, disability, or any other basis prohibited by law.
GSK offers a supportive and friendly working environment, and they are looking for someone who thrives in a collaborative setting and is passionate about delivering results. Qualified candidates interested in this GSK Regulatory Submission Lead opportunity are encouraged to apply at the earliest opportunity.
