Regulatory Specialist

2 tygodni temu

Warszawa, Mazovia, Polska 9605 GSK Services Sp z o.o. Pełny etat

Job Overview

We are seeking an experienced Regulatory Specialist to join our team as a Global Labelling Expert.

About the Role

In this role, you will be responsible for providing expert guidance on labelling requirements and regulations across multiple markets and regions.

You will work closely with cross-functional teams to ensure that all labelling documents and submissions meet regulatory requirements and company standards.

The ideal candidate will have a strong understanding of labelling regulations and experience in managing regional/country labelling documents.

Key Responsibilities

  • Provide expert guidance on labelling requirements and regulations across multiple markets and regions.
  • Work closely with cross-functional teams to ensure that all labelling documents and submissions meet regulatory requirements and company standards.
  • Manage regional/country labelling documents and data in regulatory systems.
  • Collaborate with GRA Labelling colleagues, Regulatory Matrix Teams, and Local Operating Companies to ensure timely update, management, and communication of quality regional and local labelling/Product Information (PI) and supporting documentation required for local submissions.
  • Author and compile Regional/Country PI as per regulatory authority labelling requirements and GSK process and standards.
  • Author and compile market-specific supporting documentation for labelling submissions in accordance with regulatory authority requirements and GSK process and standards.
  • Support global and local GRA team members through preparation of other labelling documents as required.
  • Complete quality and consistency checks of labelling document content.
  • Efficiently coordinate and manage labelling documentation and data in regulatory systems.
  • Provide advice regarding regulatory authority labelling requirements and GSK labelling process and standards to GRA global/local roles and via Regulatory Matrix Teams.
  • Effectively communicate with GSK staff (including GRA, Global safety and medical, and Local Operating Companies) to author, compile, and deliver quality labelling documents. May communicate with Regulatory Agencies and third parties on behalf of GRA labelling staff.
  • Support other regulatory functions and participate in other projects and activities as needed, such as leading the design and implementation of changes to labelling processes and evaluation of new agency labelling requirements.
  • For some roles, may be required to perform translation of labelling text into identified languages.

Requirements

  • Relevant experience (in pharmaceutical industry, life sciences research or regulatory)
  • Masters degree Area of Specialisation: Science or Life Sciences (must have)
  • Successfully performed within a regulated or quality-critical environment (such as pharmaceutical industry research, pharmacy, safety or regulatory)
  • Understanding of labelling (e.g. through direct or indirect exposure to the management of labelling documents/submissions/data)
  • Experience in updating and managing Regional/Country Labeling documents.
  • Knowledge of labelling regulations/requirements in 1 or more regions (EU preferred)
  • Attention to detail, significant experience of document and database management, excellent organization and time management skills to handle multiple tasks
  • Excellent written and verbal English language communication skills and ability to present information to diverse colleagues in global locations in a clear and concise manner
  • Ability to think flexibly in order to meet constantly shifting priorities and timelines
  • Understanding of the pharmaceutical industry, drug development environment, and regulatory processes
  • Ability to negotiate solutions to moderate labeling issues and proactively identify improvements for labelling processes.

What We Offer

  • Career at one of the leading global healthcare companies
  • Hybrid type of work - 2/3 days per week from the office
  • Contract of employment
  • Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
  • Life insurance and pension plan
  • Private medical package with additional preventive healthcare services for employees and their eligible counterparts
  • Sports card (Multisport)
  • Possibilities of development within the role and company's structure
  • Personalized learning approach (mentoring, online training platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
  • Extensive support of work life balance (flexible working solutions, health & well-being activities)
  • Supportive community and integration events
  • Modern office with creative rooms, fresh fruits everyday
  • Free car and bike parking, locker rooms and showers

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive.

We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology).

Location: Warsaw, Poland

Estimated Salary: €50,000 - €70,000 per year

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