Regulatory Compliance Specialist
6 days ago
Elevate your career in Regulatory Affairs at Emporium Human Capital as we seek an experienced Regulatory Compliance Specialist. This pivotal role demands a seasoned professional to oversee the management of regulatory work streams, ensuring seamless submissions and compliance with relevant Acts, Regulations, and Guidelines.
We are looking for an exceptional candidate with a proven track record in end-to-end regulatory activities, preferably in human medicines, including complementary medicines and medical devices. The ideal candidate will possess sound project management capabilities, demonstrated ability to consistently deliver quality results under tight deadlines, and experience in CTD software builder and compilation of eCTD dossier applications.
The selected individual will play a critical role in maintaining current knowledge of relevant legislation, regulations, and guidelines, and will be responsible for coordinating and submitting new product applications in South Africa and other applicable territories.
Key Responsibilities- Manage Work Streams: Oversee assigned portfolios of products, ensuring timely submission of regulatory materials to relevant authorities.
- Internal and External Stakeholder Management: Establish effective relationships with internal departments and external stakeholders, including SAHPRA, MRA's, and third-party partners.
- Regulatory Prioritization and Resource Allocation: Determine regulatory priorities and allocate resources and workloads accordingly.
- Submission Coordination: Review agency submission requirements, coordinate with stakeholders, and submit new product applications in South Africa and other territories.
- Bachelor's Degree in Pharmacy or related field, 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.
- Sound Project Management Capabilities, Proven Ability to Deliver Quality Results Under Tight Deadlines.
- CTD Software Builder and eCTD Dossier Applications Experience.
- Strategic Thinking, Active Learning, Systems and Operations Analysis, Cost Management Skills.
- Cross-Functional Skills, IT Skills including Microsoft Office.
We offer a competitive salary of R1 million to R1.2 million per annum, commensurate with experience, plus benefits. If you are a motivated and detail-oriented professional seeking a challenging role in Regulatory Affairs, please apply.
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