Pharmaceutical Regulatory Specialist Job

7 days ago


Randburg, Gauteng, South Africa Mvg Recruitment Specialists Full time

Job Overview:

A leading pharmaceutical manufacturing facility seeks a skilled Regulatory Affairs Pharmacist to oversee the registration process and ensure compliance with regulatory requirements.

Responsibilities:

  • Submission and Follow-up: Submit and follow up on dossier submissions to relevant health authorities.
  • Regulatory Authority Liaison: Build and maintain strong relationships with Regulatory Authorities to streamline application processes.
  • System Implementation: Develop, audit, and implement Regulatory systems to ensure efficiency and effectiveness.
  • Policy Development: Create, review, and adhere to SOPs and local Regulatory Guidelines.

Qualifications:

  • Education: Bachelor's degree in Pharmacy and registration with the South African Pharmacy Council.
  • Experience: 2-5 years' experience in Regulatory Affairs, preferably in orthodox, human medicines.
  • Regulatory Knowledge: Up-to-date knowledge of Acts, Regulations, and Guidelines governing the pharmaceutical industry.
  • Software Proficiency: Familiarity with CTD software builder and eCTD application compilation tools like docuBridge.
  • Regional Compliance: Understanding of Regulatory requirements for medical products in South Africa and other territories.
  • Leadership and Communication: Proven project management and leadership skills, with ability to work under pressure and communicate effectively with colleagues.


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