Global Regulatory Expert

3 dni temu

Warszawa, Mazovia, Polska GlaxoSmithKline Pełny etat
About the Role:

GSK's Global Regulatory Centres are responsible for regulatory affairs functions, bringing together operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labelling outputs, license maintenance, and lifecycle management dossiers.

We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Poland. As a key member of our Product Variations team, you will lead and participate in global CMC variation projects and Global Supply Chain centrally driven change programs.

The successful candidate will have relevant experience in regulatory affairs, pharmaceutical industry, and post-approval CMC regulatory procedures. A Bachelor's or Master's degree in biotechnology, chemical technology, pharmacy, chemistry, or other related sciences/technical fields is required.

Your Key Responsibilities:

  • Managing multiple CMC variations and source transfers for Finished Products, Intermediates, and Active Pharmaceutical Ingredients.
  • Defining and agreeing regulatory strategy, completing data assessment, and ensuring authored regulatory dossier compliance with GlaxoSmithKline regulatory processes and external requirements.
  • Working with colleagues in Global Supply Chain, Global Regulatory Groups, and GSK Local Operating Companies worldwide to deliver high-quality dossiers on time.
  • Building and maintaining good relationships with internal and external stakeholders.
  • Monitoring regulatory intelligence and acting proactively on identified changes to regulatory requirements.
  • Identifying improvement opportunities for CMC Regulatory processes, policies, and systems.

Key Requirements:

  • Relevant experience in regulatory affairs, pharmaceutical industry (familiarity with post-approval CMC regulatory procedures and ICH CTD documentation).
  • Bachelor's or Master's degree in biotechnology, chemical technology, pharmacy, chemistry, or other related sciences/technical fields.
  • Understanding of the pharmaceutical industry, drug development environment, and regulatory processes.
  • Attention to detail with emphasis on accuracy and completeness.
  • Ability to handle multiple tasks, meet constantly shifting priorities, and schedule work to meet business needs.
  • Flexible and analytical thinking to independently provide solutions to issues.
  • Excellent interpersonal skills; ability to communicate clearly and effectively, work in a diverse team environment, and build relationships across a large organization.
  • Excellent written and verbal communication skills in English and Polish.

Why Choose Us:

  • We offer a Performance with Choice programme, providing flexibility in working mode and working hours.
  • Our company provides a supportive and friendly working environment.
  • Opportunities for career growth and development within the role and company structure.
  • A wide range of benefits, including Medical Plan, Life Insurance, and Employee Retirement Programme.

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