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Regulatory Affairs Specialist

2 tygodni temu

Warszawa, Mazovia, Polska TN Poland Pełny etat

About the Role

We are seeking a Senior Regulatory Specialist, CTA/IND to join our Polish Hub.

Key Responsibilities:
  • Develop and implement regulatory strategies for CTA/IND submissions, ensuring compliance with GSK policy and procedures.
  • Collaborate with cross-functional teams to achieve project goals and deliver high-quality results.
  • Manage and maintain accurate records of regulatory submissions and communications.
  • Provide expert advice on regulatory matters to internal stakeholders.
  • Stay up-to-date with relevant regulations and guidelines to ensure continued compliance.
Required Skills and Qualifications:
  • Bachelor's degree in biological or healthcare science.
  • Relevant experience within Regulatory Affairs in the R&D, pharmaceutical industry or clinical trials.
  • Strong understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
  • Able to communicate effectively in English and Polish.
  • Excellent organizational skills and attention to detail.
Benefits:
  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Flexible work arrangements and work-life balance support.
  • Access to cutting-edge technology and resources.