Regulatory Affairs Specialist
1 month ago
Emporium is seeking a highly skilled Senior Regulatory Affairs Pharmacist to join our team in Midrand. As a key member of our regulatory affairs team, you will be responsible for managing work streams and reporting on assigned portfolios of products.
Key Responsibilities:
- Manage internal product queries from relevant departments and external product queries from the SAHPRA, other MRA's and third-party stakeholders.
- Establish regulatory priorities and allocate resources and workloads.
- Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards.
- Co-ordinate and submission of 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 the registration applications for submission to the regulatory authorities.
- Work in collaboration with internal and external stakeholders to assess regulator's submissions requirements.
- Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines.
Requirements:
- Bachelor's Degree in Pharmacy. 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 for end-to-end regulatory activities.
- Demonstrable experience across the product development, commercialization and maintenance lifecycle.
- Sound project management capabilities.
- Proven ability to consistently deliver to quality, time and cost standards.
- Good Manufacturing Practices (GMP).
- Pharmaceutical production experience or exposure to supplement regulatory knowledge.
What We Offer:
- A competitive salary of R950 – R1m.
- A dynamic and supportive work environment.
- Opportunities for professional growth and development.
How to Apply:
Send your MS Word format CV to jobs@emporium.co.za and use POS24325 – Snr RA Pharma in the subject line.
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