Regulatory Affairs Specialist
15 hours ago
Elevate your career in Regulatory Affairs with a leading role at Emporium Human Capital. As a Regulatory Affairs Pharmacist, you will be responsible for ensuring compliance with regulatory requirements and maintaining the highest standards of quality.
About the RoleThis is a dynamic opportunity to join our team as a Regulatory Affairs Pharmacist. Your primary focus will be on managing work streams, reviewing regulatory agency submissions, and coordinating the submission of new product applications. You will also be responsible for developing regulatory strategies and implementation plans, conducting dossier due diligence, and preparing registration applications for submission to regulatory authorities.
Main Responsibilities- Manage work streams for- and report on assigned portfolio of products: internal product queries from relevant departments and external product queries from SAHPRA, other MRAs and third-party stakeholders
- Establish regulatory priorities and allocate resources and workloads
- Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
- Co-ordination and submission of new product applications in South Africa and other applicable territories
- Develop regulatory strategies and implementation plans for the preparation and submission of new products
- Conduct dossier due diligence to ensure all data gaps are addressed, in preparation for dossier call up and registration of complementary medicines and other human medicines
- Prepare the registration applications for submission to the regulatory authorities
- Work in collaboration with internal and external stakeholders to assess regulators' submissions requirements
- Bachelors Degree in Pharmacy; Diploma in Pharmacy and Registration with the South African Pharmacy Council
- +/- 5 years experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end regulatory activities
- 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 (GMP)
- Pharmaceutical production experience or exposure to supplement regulatory knowledge
- Competitive salary: R900k - R1m per annum
- Opportunity to work with a leading company in the pharmaceutical industry
- Professional growth and development opportunities
- Collaborative and dynamic work environment
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