Director of Regulatory Compliance

3 days ago


Cape Town, Western Cape, South Africa Modex Full time

**Job Summary**

The Head of Regulatory Affairs is a leadership position responsible for the strategic oversight of all regulatory affairs activities related to the development and registration of company products. This role is critical for establishing effective regulatory strategies across ModeX programs and for ensuring compliance with applicable regulations and guidelines set forth by regulatory authorities.

Key Responsibilities

  • Develop and execute regulatory strategies for product development, taking into account regional and global regulatory requirements.
  • Organize and oversee the preparation, review, and submission of regulatory documents to regulatory authorities.
  • Monitor and interpret changes in regulations, guidelines, and legislation that may impact the company's products and operations.
  • Serve as the primary point of contact for regulatory agencies and represent the company in meetings, discussions, and negotiations.
  • Collaborate with cross-functional teams to ensure regulatory requirements are integrated into development plans, clinical trials, manufacturing processes, and labeling.


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