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Regulatory Affairs Specialist

vor 2 Monaten


Munich, Bayern, Deutschland Life Science People Vollzeit
Regulatory Affairs Consultant

This role involves conducting research and development stages to clinical trials and NDA/BLA submissions.

Key Responsibilities:
  • Develop and execute regulatory strategies to support drug development and commercialization.
  • Coordinate with internal and external stakeholders to compile necessary data and documents for submission to regulatory authorities.
  • Ensure regulatory compliance across all stages of product development, including preclinical, clinical, and post-marketing activities.
  • Develop a global agency interaction strategy.
Requirements:
  • Bachelor's or advanced degree in life sciences, regulatory affairs, pharmacy, or a related field.
  • 10+ years of experience in regulatory affairs, with specific experience in pharmaceutical development.
  • Thorough understanding of clinical development and regulatory strategy.
  • Strong project management skills, with the ability to work effectively across multiple projects simultaneously.
  • Ability to interpret complex scientific data and provide clear regulatory guidance.