GSK

Regulatory Specialist – Submission Delivery Excellence

GSK

full-time

Posted on:

Location Type: Hybrid

Location: Poznan • Poland

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 PLN 89,250 - PLN 148,750 per year

About the role

  • Works closely with global submission teams and regulatory contacts to deliver submissions.
  • Responsible to deliver marketing applications and lifecycle maintenance submissions including renewals and site registrations.
  • Coordinates MSR for various types of submission and executes agreed dossier strategies independently.
  • Assists in scenario planning for multiple regulatory strategies.
  • Executes coordination, preparation, and delivery of regulatory registration samples in partnership with stakeholders.
  • Identifies and escalates risks associated with submission delivery.
  • Participates in process improvement initiatives as required.
  • Mentors and trains team members as necessary.

Requirements

  • Degree in a biological, healthcare or scientific discipline or extensive experience in the Regulatory Affairs area.
  • Understanding of the pharmaceutical industry, R&D processes and objectives.
  • Ability to interpret regulations.
  • Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment.
  • Ability to think flexibly in order to meet shifting priorities and timelines.
  • Good organizational skills, attention to detail and commitment to deliver high quality output in a timely manner.
  • Ability to proactively identify and mitigate risks and potential bottlenecks, apply sound judgement when determining if/when to escalate issues, and effectively interact with stakeholders to ensure transparency of submission progress/status.
  • Ability to lead or co-lead multidisciplinary team meetings and facilitate discussions regarding submission content, timelines, resource allocation, risk management, etc.
Benefits
  • Private healthcare
  • Additional paid days off
  • Life insurance
  • Private pension plan
  • Fully paid parental leave & care of family member leave
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory submissionsmarketing applicationslifecycle maintenancescenario planningrisk identificationprocess improvementdossier strategiessubmission delivery
Soft Skills
mentoringtrainingorganizational skillsattention to detailflexibilityjudgmentstakeholder interactionteam leadershipcommunication