Our client is seeking a detail-oriented and experienced Regulatory Affairs Specialist to manage and coordinate regulatory activities for their pharmaceutical products in Kimberley . You will be responsible for ensuring that all products comply with national and international regulatory requirements, from product registration to post-market surveillance. This role requires a deep understanding of regulatory submissions, guidelines, and a proactive approach to navigating the complex regulatory landscape. The ideal candidate will be instrumental in facilitating the timely approval and market access of new and existing pharmaceutical products, working within a dedicated team committed to regulatory excellence in Kimberley .
Key Responsibilities
- Prepare, submit, and manage regulatory applications for product registration and variations.
- Ensure compliance with all relevant local and international pharmaceutical regulations and guidelines.
- Liaise with regulatory authorities (e.g., SAHPRA) on submission status and inquiries.
- Review and approve promotional materials to ensure regulatory compliance.
- Monitor changes in regulatory legislation and assess their impact on the company's products and operations.
Requirements
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
- Minimum of 4 years of experience in pharmaceutical regulatory affairs.
- In-depth knowledge of regulatory submission processes and requirements in South Africa and key international markets.
- Experience with regulatory databases and submission software.
- Strong analytical, problem-solving, and communication skills.
Benefits
- Competitive salary and performance-based incentives.
- Comprehensive health insurance and retirement plan.
- Support for professional development and regulatory training.
- A collaborative work setting with opportunities for growth.
- Key role in ensuring compliance and market access for pharmaceuticals in Kimberley .