Based in Midrand
BEE Candidates only to apply
Job Purpose
The Head of Regulatory Affairs holds ultimate responsibility for the RX DIVISIONS regulatory activities and oversees the development and delivery of a fully integrated regulatory strategy for the business.
- Requirements Qualifications:
- To ensure legal compliance with the relevant Health Regulatory Authorities (Country Specific where applicable), Medicines and Related Substances Control Act 101 of 1965, as amended and South African Pharmacy Act (Act 53 of 1974), and other relevant regulations
- Qualifications: B. Pharm Degree Registration with South African Pharmacy Council.
- A minimum of 8 years pharmaceutical regulatory experience is an absolute prerequisite.
- Minimum of 5 years in people or team management is required.
- This role requires a high degree of networking & collaboration both within and outside the organization.
- Demonstrated experience across the product development, commercialization and dossier maintenance lifecycle
- Drives the regulatory process to ensure timely filing of new products and variations in accordance with business and compliance objectives.
- Adopts a risk-based assessment for all regulatory submissions and anticipates potential issues for risk mitigation strategies to be in place.
- Anticipates future regulatory changes and impacts on business success.
- Communicates to ensure an excellent understanding of Regulatory Affairs
- Pays strict attention to details and accurately monitors and measures progress towards objectives and provides feedback on results whilst maintaining sense of urgency.
- Strives to maintain a high level of quality. Ensures superior execution by combining the best practices of regulatory.
- Represent RA at operational meetings such as Technical Transfer, QA, Operations, Launch, Artwork/ Packaging, Stability and Research & Development, where proactive input can then enhance operation efficiency.
- To give information and input to Responsible Pharmacist in order to facilitate appropriate decision making in order to ensure that all SAHPRA requirements are timeously met.
- Manage the regulatory and compliance aspects of any project launched into operations including acquisitions and mergers, as well as technical transfer projects.
- Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
- Internal Training, Development and Mentorship to the Rx RA Managers
- Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders.
- Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Manage activities such as internal audits or regulatory agency inspections.
- Manages a team in the Relicare India Team
- To collaborate and support the Group Regulatory Affairs function in achieving the company regulatory strategic objectives and goals.
To apply for this position: Send MS Word format CV to jobs@emporium.co.za and use Contracts Admin (POS24078) in the subject line
