Regulatory Affairs Consultant

vor 1 Woche

Munich, Deutschland Life Science People Vollzeit

Position Overview:


We are supporting a leading consultancy in their search for a Clinical Regulatory Consultant. This role will support cross functional developments teams for drug development across the development cycle. This includes research stages to clinical development until NDA / BLA.


Key Responsibilities:


  • Develop and execute regulatory strategies to support drug development and commercialisation.
  • Advise on regulatory requirements for clinical trials, marketing authorization applications, and post-approval commitments.
  • Stay updated on changes in regulatory guidelines, policies, and best practices.
  • Prepare, review, and manage regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologics License Applications (BLAs), and Marketing Authorisation Applications (MAAs).
  • Coordinate with internal and external stakeholders to compile necessary data and documents for submission to regulatory authorities (e.g., FDA, EMA).
  • Ensure timely submission of regulatory documents and responses to health authorities.
  • Ensure regulatory compliance across all stages of product development, including preclinical, clinical, and post-marketing activities.
  • Provide guidance on regulatory risk mitigation strategies and contingency planning.
  • Responsible for the global agency interaction strategy


Qualifications:

  • 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
  • Proven experience with regulatory submissions (IND, NDA, BLA, MAA) and clinical trial applications.
  • Strong project management skills, with the ability to work effectively across multiple projects simultaneously.
  • Excellent written and verbal communication skills, with a demonstrated ability to work collaboratively with cross-functional teams.
  • Ability to interpret complex scientific data and provide clear regulatory guidance.
  • EU and US Regulatory experience required

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