Senior Regulatory Affairs Specialist
4 days ago
We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Emporium Human Capital. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements for human medicines and medical devices.
Key Responsibilities- Manage work streams for internal and external product queries, regulatory agency submissions, and compliance with regulatory standards.
- Establish regulatory priorities, allocate resources, and ensure timely and accurate submission of regulatory materials.
- Develop and implement regulatory strategies for new products, including complementary medicines and medical devices.
- Conduct dossier due diligence, prepare registration applications, and ensure maintenance of existing registrations.
- Collaborate with internal and external stakeholders to assess regulatory submissions requirements and ensure alignment with company values.
- Bachelor's Degree in Pharmacy, Diploma in Pharmacy, and registration with the South African Pharmacy Council.
- At least 5 years of experience in Regulatory Affairs, preferably in human medicines and medical devices.
- Strong project management skills, ability to prioritize, and high degree of complexity and change.
- Excellent communication and negotiation skills, with ability to set standards and objectives.
- Fluency in English.
- Experience with CTD software builder and eCTD dossier applications.
- IT skills, including Microsoft Office.
- Active learning, strategic thinking, and complex problem-solving skills.
Emporium Human Capital is a leading recruitment agency dedicated to providing top talent to the pharmaceutical and healthcare industries. We are committed to fostering a culture of excellence, teamwork, and innovation.
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