Regulatory Affairs Manager (Critical Care) POS24104
Aeroton/ Crown mines
R 900 000 per annum
PURPOSE OF THE JOB
Lead the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio and team outputs. To ensure legal compliance with the relevant medicine Regulatory Authorities (Country Specific where applicable), Medicines and Related Substances Control Act and South African Pharmacy Council, ensuring timeous processing of regulatory applications.
REQUIREMENTS:
Key Job Outputs
- Assisting with internal product queries from relevant departments
- Assisting with external product queries from the SAHPRA, other MRAs and third-party stakeholders
- Establish regulatory priorities and allocate resources and workloads
- Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
- Develop regulatory strategies and implementation plans for the preparation and submission of new products
- Conduct dossier due diligence to ensure all data gaps are addressed
- Prepare the registration applications for submission to the regulatory authorities
- Work in collaboration with NBD to assess regulators submissions requirements
Closing Date: 12 April 2024
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