Regulatory Affairs Pharmacist
2 weeks ago
Emporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team. As a key member of our organization, you will be responsible for managing work streams, establishing regulatory priorities, and ensuring compliance with regulatory standards.
Key Responsibilities:
- Manage work streams for internal and external product queries
- Establish regulatory priorities and allocate resources and workloads
- Review regulatory agency submissions to ensure accuracy and compliance
- Develop regulatory strategies and implementation plans for new product applications
- Conduct dossier due diligence and prepare registration applications for submission
- Collaborate with internal and external stakeholders to assess regulator's submission requirements
- Maintain databases, trackers, and systems for regulatory-related activities
- Ensure Good Regulatory Practices and compliance with Quality Management System
Requirements:
- Bachelor's Degree in Pharmacy and registration with the South African Pharmacy Council
- 5+ years of experience in Regulatory Affairs, preferably in human medicines
- Proven experience in product development, commercialization, and maintenance lifecycle
- Sound project management capabilities and ability to prioritize tasks
- Excellent communication and collaboration skills
Preferred Qualifications:
- Experience in use of CTD software builder and compilation of eCTD dossier applications
- IT skills including Microsoft Office
- Ability to work to tight deadlines and manage multiple tasks
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