Regulatory Submission Lead

GSK

. Lead planning, compilation and delivery of regulatory submission dossiers for lifecycle activities .

Posted 9/23/2026full-timePoznan • PolandSenior💰 PLN 132,000 - PLN 220,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory submission management, including compiling and delivering electronic and paper regulatory dossiers while ensuring compliance with market regulatory requirements. Strong ability to coordinate cross-functional teams and manage submission timelines effectively.

Highest-signal resume keywords

Regulatory Affairs ExperienceECTD Principles FamiliarityRegulatory Dossier CompilationSubmission ManagementVeeva Vault Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submission ManagementRegulatory Dossier CompilationECTD PrinciplesSubmission Timeline ManagementRegulatory Content PreparationMarket Regulatory RequirementsModule 1 PreparationLocal Language Submission RequirementsTechnical Validation Issue ResolutionProcess Improvement Implementation

Soft Skills

Strong Written CommunicationStrong Verbal CommunicationOrganisational SkillsAttention to DetailAbility to Manage Competing Priorities

Tools & Technologies

Veeva VaultRegulatory Information Management Systems

Industry Keywords

PharmaceuticalClinical ResearchLifecycle MaintenanceGlobal Matrix EnvironmentRegulatory Authority Interactions

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Lead planning, compilation and delivery of regulatory submission dossiers for lifecycle activities
Coordinate with global submission teams, clinical, CMC, quality, publishing and local regulatory partners
Plan, compile and deliver electronic and paper regulatory dossiers within agreed timelines
Coordinate cross-functional inputs from clinical, CMC, quality, safety and commercial colleagues
Build, validate and quality-check electronic submission packages
Resolve technical validation issues
Maintain submission trackers, version control and milestone plans for transparency and audit readiness
Prepare responses to regulatory authority questions
Support regulatory meetings when required
Identify and implement process improvements
Coach colleagues and share best practice
Help improve patient access through regulatory excellence

Requirements

What you’ll need

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
Ability to present clear updates to stakeholders
Strong organisational skills and attention to detail
Ability to manage competing priorities under deadlines
Experience with regulatory content or information management systems such as Veeva Vault or similar platforms
Experience with CMC content, Module 1 preparation or local language submission requirements
Experience supporting regulatory authority interactions and preparing authority responses
Practical knowledge of market regulatory requirements
Experience working in a global, matrix environment and coordinating third-party service providers
Ability to act as single point of contact for submissions

Benefits

Comp & perks

Medical Plan
Life Insurance
Employee Retirement Program
Sport and recreation cards
Recreation allowance
Annual bonus
Share-based long-term incentive program eligibility
Private medical care
Additional paid days off
Private retirement plan
Fully paid parental leave
Fully paid leave to care for a family member
Supportive & friendly working environment
Professional team environment
Growth opportunities
Recruitment adjustments and support