Job Title : Regulatory Affairs Pharmacist
Location: Johannesburg, Gauteng
Salary: R62,000 - R67,000 per month
About the Role:
We are seeking a skilled and detail-oriented Regulatory Affairs Pharmacist to join our client's team. The successful candidate will be responsible for managing the regulatory aspects of our product portfolio, ensuring compliance with regulatory standards, and overseeing submissions to regulatory authorities like SAHPRA and other applicable MRAs.
Key Qualifications and Experience:
- Bachelor's degree in Pharmacy or Diploma in Pharmacy
- Registration with the South African Pharmacy Council
- 3 to 5 years of experience in Regulatory Affairs, preferably in human medicines
- Experience across the product development, commercialization, and maintenance lifecycle
- Sound project management capabilities
- Proven ability to consistently meet quality, time, and cost standards
Key Job Responsibilities:
- Manage and report on the assigned product portfolio
- Handle internal and external product queries from departments, SAHPRA, and third-party stakeholders
- Develop regulatory strategies and plans for new product submissions
- Review and prepare submissions for regulatory agencies, ensuring accuracy and compliance
- Conduct dossier due diligence and coordinate new product applications in South Africa and other regions
- Maintain and update product registrations as per legislation and regulatory guidelines
- Ensure current knowledge of relevant Acts, Regulations, and Guidelines within the pharmaceutical industry
- Provide internal training and mentorship on regulatory matters
- Foster strong relationships with Regulatory Authorities and other stakeholders
- Ensure regulatory compliance and support internal audits and inspections
Core Competencies:
- Experience with CTD software builder and eCTD application compilation
- Strong regulatory strategy development skills
- Excellent communication and collaboration abilities
If you are passionate about regulatory affairs and have the expertise to ensure product compliance, we’d love to hear from you!
