Regulatory Affairs Specialist
2 weeks ago
Emporium is seeking a highly skilled Senior Regulatory Affairs Pharmacist to join our team in Midrand. As a key member of our Regulatory Affairs department, you will be responsible for managing work streams and reporting on assigned portfolios of products.
Key Responsibilities:
- Manage internal and external product queries from relevant departments and regulatory authorities
- Establish regulatory priorities and allocate resources and workloads
- Review regulatory agency submissions to ensure timelines, accuracy, and compliance with regulatory standards
- Coordinate and submit new product applications in South Africa and other applicable territories
- Develop regulatory strategies and implementation plans for new products
- Conduct dossier due diligence to ensure data gaps are addressed
- Prepare registration applications for submission to regulatory authorities
- Collaborate with internal and external stakeholders to assess regulator's submissions requirements
- Maintain existing registrations and update databases, trackers, and systems
- Comply with Quality Management System requirements and maintain Good Regulatory Practices
- Stay up-to-date with relevant Acts, Regulations, and Guidelines
- Internal training and mentoring of peers
- Establish and maintain effective relationships with Regulatory Authorities and stakeholders
Requirements:
- Bachelor's Degree in Pharmacy and Registration with the South African Pharmacy Council
- +-5 years' experience in Regulatory Affairs, preferably in human medicines
- Demonstrable experience across the product development, commercialization, and maintenance lifecycle
- Sound project management capabilities
- Proven ability to consistently deliver to quality, time, and cost standards
- Good Manufacturing Practices and Pharmaceutical production experience
What We Offer:
- Competitive salary
- Opportunities for professional growth and development
- Collaborative and dynamic work environment
How to Apply:
Please send your MS Word format CV to jobsemporium.co.za and use POS24325 – Snr RA Pharma in the subject line.
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