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Pharmaceutical Regulatory Compliance Specialist
2 weeks ago
Key Performance Indicators (KPIs):
The following KPIs will be used to measure the success of this role:
- Timely completion of work streams for assigned products.
- Accuracy and completeness of internal and external product queries.
- Effective relationships maintained with regulatory authorities, MRAs, and third-party stakeholders.
- Compliance with regulatory standards and guidelines.
- Successful submission of new product applications in South Africa and other applicable territories.
- Development and implementation of regulatory strategies and plans.
- Completion of dossier due diligence and preparation for dossier call-up and registration.
- Preparation and submission of registration applications to regulatory authorities.
- Collaboration with internal and external stakeholders to assess regulator's submissions requirements.
- Maintenance and update of existing registrations, adhering to relevant legislation, regulations, and guidelines.
- Update and maintenance of databases, trackers, and systems for regulatory activities.
- Compliance with quality management system requirements.
- Maintenance of current knowledge of relevant Acts, Regulations, and Guidelines.
- Internal training and mentoring of peers when required.
- Establishment and maintenance of effective relationships with regulatory authorities, internal, and external stakeholders.
- Development and implementation of regulatory affairs systems, policies, and procedures.
- Support of activities such as internal audits or regulatory agency inspections.
- Alignment of personal and company values.
