Regulatory Affairs Specialist for Human Medicines and Complementary Therapies
1 month ago
Job Summary
">This position is focused on managing work streams for a portfolio of products, ensuring timely and accurate regulatory submissions to relevant authorities. The successful candidate will establish priorities, allocate resources, and review agency submissions for compliance with regulations.
">About the Role
">The Senior Regulatory Affairs Pharmacist will coordinate new product applications, develop regulatory strategies, and conduct dossier due diligence to ensure data gaps are addressed. This role also involves preparing registration applications, maintaining existing registrations, and updating databases and systems for regulatory activities.
">Key Responsibilities
">- Manage work streams for assigned portfolio of products, reporting on progress and milestones.
- Establish regulatory priorities, allocate resources, and review agency submissions for compliance with regulations.
- Coordinate new product applications, develop regulatory strategies, and conduct dossier due diligence.
- Pprepare registration applications, maintain existing registrations, and update databases and systems.
- Maintain current knowledge of relevant Acts, Regulations, and Guidelines pertaining to the pharmaceutical industry.
- Provide internal training and mentoring, establishing effective relationships with Regulatory Authorities and stakeholders.
- Formulate or implement regulatory affairs systems, policies, and procedures to ensure regulatory compliance.
- Support activities such as internal audits or regulatory agency inspections.
Requirements
">- Bachelors 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 complementary therapies.
- Demonstrable experience across the product development, commercialization, and maintenance lifecycle.
- Sound project management capabilities, proven ability to deliver to quality, time, and cost standards.
- Good Manufacturing Practices (GMP) knowledge and pharmaceutical production experience.
- Cross-functional skills: Ability to network, liaise, and negotiate with others.
Salary and Benefits
">We offer an attractive salary range of R950,000 to R1,000,000 per annum, reflecting the seniority and complexity of this role. This position comes with excellent benefits, including opportunities for professional growth and development.
">About Us
">We are Emporium Human Capital, a leading recruitment agency specializing in the healthcare and pharmaceutical sectors. We pride ourselves on our expertise, integrity, and commitment to delivering exceptional service to our clients and candidates.
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