Regulatory Affairs Specialist

1 tydzień temu

Warszawa, Mazovia, Polska GlaxoSmithKline Pełny etat
Job Description:

GSK is a global biopharma company that unites science, technology, and talent to get ahead of disease together. Our ambition is to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns.

We are looking for a skilled Regulatory Affairs Specialist to join our team in Poland. As a key member of our Global Regulatory Centres, you will play a crucial role in maintaining GSK's portfolio on the markets.

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 Responsibilities:

  • Manage multiple CMC variations and source transfers for Finished Products, Intermediates, and Active Pharmaceutical Ingredients.
  • Define and agree regulatory strategy, complete data assessment, and ensure authored regulatory dossier compliance with GlaxoSmithKline regulatory processes and external requirements.
  • Work with colleagues in Global Supply Chain, Global Regulatory Groups, and GSK Local Operating Companies worldwide to deliver high-quality dossiers on time.
  • Build and maintain good relationships with internal and external stakeholders.
  • Monitor regulatory intelligence and act proactively on identified changes to regulatory requirements.
  • Identify improvement opportunities for CMC Regulatory processes, policies, and systems.

Our 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.

What We Offer:

  • Performance with Choice – flexibility in working mode (hybrid between office and remote work based on employee needs), flexible working hours.
  • Established job in an international, well-known pharmaceutical company.
  • Opportunity to work in professional teams playing crucial roles in maintaining GSK's portfolio on the markets.
  • Opportunity to work within GSK standards and documentation applied globally.
  • Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus).
  • Recognition awards for additional achievements.
  • Supportive and friendly working environment.
  • Possibilities of development within the role and company structure.

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