Regulatory Affairs Specialist for Pharmaceutical Compliance
4 weeks ago
At Emporium Human Capital, we are seeking a skilled Regulatory Affairs Specialist to oversee the compliance of our pharmaceutical products.
Salary: R900,000 - R1,000,000 per annum
Key Responsibilities:- Manage work streams for assigned portfolio of products, including internal and external queries
- Establish regulatory priorities and allocate resources and workloads
- Review regulatory agency submissions to ensure timelines, accuracy, and compliance
- Co-ordinate and submit 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
- Prepare registration applications for submission to regulatory authorities
- Work with internal and external stakeholders to assess regulator's submission requirements
- Maintain existing registrations in accordance with relevant legislation and regulations
Required Skills and Qualifications:
- Bachelor's Degree in Pharmacy or related field
- 5+ years experience in Regulatory Affairs, preferably in human medicines
- Demonstrable experience across product development, commercialization, and maintenance lifecycle
- Sound project management capabilities
- Proven ability to deliver to quality, time, and cost standards
- Good Manufacturing Practices (GMP)
- Pharmaceutical production experience or exposure to supplement regulatory knowledge
About Emporium Human Capital:
We are a leading recruitment agency specializing in placing top talent in various industries. Our team is dedicated to providing exceptional service and ensuring a seamless hiring experience.
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