Pharmaceutical Regulatory Specialist Job
7 days ago
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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