Regulatory Strategy and Compliance Expert
3 days ago
The Regulatory Affairs Manager will be measured on their ability to ensure compliance with regulatory requirements, maintain effective relationships with stakeholders, and deliver high-quality results under tight deadlines.
Responsibilities:
This role involves establishing regulatory priorities, allocating resources, monitoring progress, and ensuring compliance with regulatory requirements. The successful candidate will also be responsible for coordinating the submission of new product applications, conducting dossier due diligence, and preparing registration applications for submission to regulatory authorities.
Requirements:
This position requires a Bachelor's degree in Pharmacy or Diploma in Pharmacy, registration with the South African Pharmacy Council, and at least 5 years of experience in Regulatory Affairs. Strong project management skills, leadership abilities, and proficiency in CTD software builder are essential for success in this role.
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