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jobs description

Job summary
The Head of Regulatory Affairs is responsible for regulatory activities and developing a regulatory strategy
Ensuring legal compliance with relevant Health Regulatory Authorities and other regulations
Minimum 8 years pharmaceutical regulatory experience and 5 years in people or team management required

Job seniority: mid-to-senior level

• Drive the regulatory process for timely filing of new products and variations
• Assess and mitigate potential risks for regulatory submissions
• Anticipate future regulatory changes and communicate their impacts
• Maintain accurate monitoring and measurement of progress
• Represent Regulatory Affairs at operational meetings
• Provide input to Responsible Pharmacist for decision making
• Manage regulatory and compliance aspects of projects and acquisitions
• Stay updated with relevant Acts, Regulations, and Guidelines
• Provide internal training, development, and mentorship to Rx RA Managers
• Establish and maintain... relationships with Regulatory Authorities and stakeholders
• Formulate or implement regulatory affairs systems, policies, and procedures
• Manage internal audits or regulatory agency inspections
• Collaborate with Group Regulatory Affairs to achieve company objectives

• B. Pharm Degree and registration with South African Pharmacy Council
• Minimum 8 years pharmaceutical regulatory experience
• Minimum 5 years in people or team management
• High degree of networking and collaboration
• Experience across product development, commercialization, and dossier maintenance
• In-depth understanding of the pharmaceutical industry and regulatory requirements

Key Skills Needed
• Leadership
• Strategic Thinking
• Project Management
• Communication
• Problem-Solving
• Industry Knowledge
• Change Management
• Stakeholder Management

Original job Head of Regulatory Affairs posted on GrabJobs ©. To flag any issues with this job please use the Report Job button on GrabJobs
Johannesburg South Africa


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