Regulatory Affairs Specialist for Pharmaceutical Compliance
3 weeks ago
Job Summary:
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Emporium Human Capital. This role will be responsible for ensuring compliance with regulatory requirements for pharmaceutical products.
About the Role:
The successful candidate will have a strong background in regulatory affairs, preferably in human medicines, including complementary medicines and medical devices. They will be responsible for managing work streams, reviewing regulatory agency submissions, and coordinating the submission of new product applications.
Key Responsibilities:
- Manage portfolios of products, including internal and external queries
- Establish regulatory priorities, allocate resources, and review submissions for accuracy and compliance
- Develop regulatory strategies and implementation plans for new products
- Conduct dossier due diligence, prepare registration applications, and maintain existing registrations
- Collaborate with stakeholders to assess regulators' submission requirements and ensure Good Regulatory Practices
- Update and maintain databases, trackers, and systems for regulatory activities
Requirements:
- Bachelor's Degree in Pharmacy, Diploma in Pharmacy, and registration with the South African Pharmacy Council
- 5+ years of experience in Regulatory Affairs, preferably in human medicines
- Demonstrable experience across the product development, commercialization, and maintenance lifecycle
- Sound project management capabilities, ability to prioritize and work to tight deadlines
- Familiarity with CTD software builder, eCTD dossier applications, and Microsoft Office
Salary: R900k - R1m per annum
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