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Senior Regulatory Manager

2 weeks ago

Cape Town, Western Cape, South Africa Modex Full time
Job Title: Head of Regulatory AffairsAbout ModeX Therapeutics

ModeX Therapeutics is a clinical-stage biopharmaceutical company developing next-generation multispecific antibodies and vaccines for cancer and infectious disease.

Job Summary

We are seeking a highly experienced Head of Regulatory Affairs to lead our regulatory affairs activities. This role is critical for establishing effective regulatory strategies across ModeX programs and ensuring compliance with applicable regulations and guidelines.

Responsibilities
  • Develop and execute regulatory strategies for product development, particularly non-clinical and clinical development, taking into account regional and global regulatory requirements.
  • Provide strategic input and guidance to cross-functional teams to ensure regulatory compliance.
  • Organize and oversee the preparation, review, and submission of regulatory documents to regulatory authorities.
Requirements
  • Advanced degree (M.S. Ph.D., M.D., or equivalent) in a relevant scientific discipline.
  • Extensive experience (12+ years) in the biotech or pharmaceutical industry, with a focus on non-clinical and clinical development; minimum of 10 years in oncology regulatory affairs required; additional experience in infectious diseases preferred.
  • Excellent communication and presentation skills, with the ability to effectively convey scientific concepts and development strategies to both technical and non-technical audiences.