Senior Regulatory Affairs Specialist, Chemistry Manufacturing and Controls

3 tygodni temu


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

About the Role:

We are seeking a highly skilled Senior Regulatory Affairs Specialist, Chemistry Manufacturing and Controls to join our team at GSK. The successful candidate will be responsible for ensuring that our pharmaceutical and vaccine products are safe, effective, and of high quality for patient use.

Key Responsibilities:

  • Manage multiple CMC new files and CTA assignments for pharmaceutical, biopharm, and vaccine products, including responses to agency questions.
  • Define and agree upon regulatory strategies, complete data assessments, and ensure CMC dossiers are authored in compliance with company regulatory processes and external requirements.
  • Collaborate with colleagues in Global Manufacturing & Supply and GSK Local Operating Companies worldwide to deliver high-quality dossiers on time.
  • Monitor regulatory intelligence and act proactively on identified changes to regulatory requirements.
  • Communicate effectively, both in person and virtually, using digital platforms.
  • Act as a subject matter expert in regulatory processes.
  • Evaluate and implement innovative solutions for CMC regulatory processes, policies, and systems.
  • Support digital transformation through active participation in building digital skills.

Requirements:

  • Extensive experience in regulatory affairs and the pharmaceutical industry, with familiarity with CMC regulatory procedures and ICH CTD documentation.
  • Bachelor's or Master's degree in biotechnology, pharmacy, chemistry, or a related science or technical field.
  • Attention to detail, excellent organization, and time management skills.
  • Excellent written and verbal English language communication skills and ability to present information to diverse colleagues in global locations.
  • Understanding of the pharmaceutical industry, drug development environment, and regulatory processes.
  • Adaptability and learning: a commitment to ongoing professional development with proven ability to learn and apply new concepts.
  • Mindset that embraces digital transformation and innovation.

About GSK:

GSK is a global biopharma company with a special purpose: to unite science, technology, and talent to get ahead of disease together. 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.

Join Our Team:

We are committed to creating a workplace where everyone feels welcome, valued, and included. We offer a wide range of benefits, including performance with choice, flexible working hours, and opportunities for professional growth and development. If you share our ambition, join us at this exciting moment in our journey to get ahead together.



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