Senior Regulatory Affairs Pharmacist

Pharmacist

We are seeking a results-driven Senior Regulatory Affairs Pharmacist to provide support to the Regulatory team by implementing and developing regulatory compliance strategies with the relevant departments within the company and with external partners.
 
Our client is one of the global pharmaceutical leaders committed to improving health and increasing access to quality Health solutions worldwide.  
 
Your Bachelor’s degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council is required with a minimum of 3 to 5 years experience in Regulatory Affairs, preferably in human medicines. A demonstrable experience across the product development, commercialization, and maintenance lifecycle, with sound project management capabilities
In this role, you will be …
  • Reviewing documentation, and processes by managing work streams and reports on the assigned portfolio of products
  • Developing and enacting regulatory compliance strategies across organizational structures and maintaining the relevant Regulations and Guidelines
  • Co-ordination and submission of new product applications in the country
  • Documenting compliance-related processes, audits, and maintaining records or reports
  • Your experience in the use of CTD software builder and compilation of eCTD applications, with basic cost management skills and the ability to cope with a high degree of complexity and change is an added advantage.
 
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