Global Regulatory Submissions Lead

GlaxoSmithKline; Poznań; Hybrid; PLN 132,000 - 220,000; Full time

Benefits offered by this job

Medical Plan

Life Insurance

Employee Retirement Program

Sport and recreation cards

Recreation allowance

Annual bonus

Job summary

GlaxoSmithKline in Poland is seeking a Regulatory Submission Lead to plan, compile and deliver high-quality dossiers for lifecycle activities. You will coordinate inputs from clinical, CMC, quality and regulatory teams, ensuring timely submissions and audit readiness.

The role emphasizes global collaboration, strong English communication and process improvements, with a hybrid work arrangement combining on-site and remote days. Growth opportunities are highlighted in a world-class pharma setting.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, chemistry, regulatory affairs or related discipline.

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 practice.

Skills

Regulatory strategies

Agile planning

Business acumen

Change management

Digital fluency

Learning agility

Problem solving

Education

Bachelor’s degree in life sciences, pharmacy, chemistry, regulatory affairs or related discipline

Tools

Veeva Vault

Job description

GlaxoSmithKline in Poland is seeking a Regulatory Submission Lead to plan, compile and deliver high-quality dossiers for lifecycle activities. You will coordinate inputs from clinical, CMC, quality and regulatory teams, ensuring timely submissions and audit readiness.

The role emphasizes global collaboration, strong English communication and process improvements, with a hybrid work arrangement combining on-site and remote days. Growth opportunities are highlighted in a world-class pharma setting.