Regulatory Affairs Pharmacist
3 weeks ago
Emporium is seeking a highly skilled Regulatory Affairs Pharmacist to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our pharmaceutical products.
Key Responsibilities:- Manage work streams for- and report on the assigned portfolio of products
- Assist with internal product queries from relevant departments
- Assist with external product queries from regulatory authorities and third-party stakeholders
- Establish regulatory priorities and allocate resources and workloads
- Review regulatory agency submissions to ensure accuracy, comprehensiveness, 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 all 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 current knowledge of relevant Acts, Regulations, and Guidelines pertaining to the pharmaceutical industry
- Bachelor's degree in Pharmacy or Diploma in Pharmacy and Registration with the South African Pharmacy Council
- 3 to 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
- Competitive salary
- Opportunities for professional growth and development
- Collaborative and dynamic work environment
To apply for this position, please send your MS Word format CV to jobs@emporium.co.za and use POS24203 in the subject line.
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