Job Requirements

2 to 3 years experience in compilation and submission of Act 101 dossiers
Knowledge of Act 36 dossiers submissions
CTD submission experience
Vet industry experience
Knowledge of regulatory submissions in Botswana, Nambia, Zambia, Zimbabwe and Mozambique

Job Duties

Regulatory Affairs Duties

Regulatory Submissions:
- Prepare and submit regulatory documents to health authorities (e.g., FDA, EMA).
- Ensure that submissions comply with regulatory guidelines and requirements.
Compliance:
- Monitor and interpret regulatory requirements and guidelines.
- Ensure company practices and products comply with national and international regulations.
Product Registration:
- Manage the process of registering new products or updating the registration of existing products.
- Coordinate with regulatory bodies for product approvals.
Labeling and Advertising:
- Review and approve product labeling, packaging, and advertising materials to ensure they meet regulatory standards.
- Ensure that marketing materials are compliant with regulatory requirements.
Communication:
- Liaise with regulatory authorities and industry groups.
- Maintain up-to-date knowledge of current and emerging regulations.

Quality Assurance Duties

Quality Systems Management:
- Develop, implement, and maintain quality management systems (QMS).
- Ensure QMS complies with Good Manufacturing Practices (GMP) and other relevant standards.
Audits and Inspections:
- Conduct internal audits to ensure compliance with SOPs and regulatory requirements.
- Prepare for and manage external inspections by regulatory agencies.
Documentation:
- Oversee the creation, review, and maintenance of quality-related documentation.
- Ensure accurate and complete documentation of all quality processes and activities.
Deviation and CAPA Management:
- Investigate deviations and non-conformances.
- Implement corrective and preventive actions (CAPA) to address quality issues.
Training:
- Develop and deliver training programs for staff on regulatory and quality standards.
- Ensure that all personnel are trained and competent in relevant regulatory and quality practices.
Risk Management:
- Conduct risk assessments to identify potential quality issues.
- Develop and implement risk mitigation strategies.
Product Quality Reviews:
- Conduct regular reviews of product quality and performance.
- Ensure that products meet quality specifications and standards throughout their lifecycle.

Additional Duties

Collaboration:
- Work closely with other departments, such as R&D, manufacturing, and marketing, to ensure regulatory and quality requirements are met.
- Participate in cross-functional teams to support product development and commercialization.
Continuous Improvement:
- Identify opportunities for process improvements in regulatory and quality systems.
- Implement changes to enhance efficiency and compliance.
Reporting:
- Prepare and present reports on regulatory and quality metrics.
- Keep senior management informed about compliance status and quality performance.

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