SENIOR REGULATORY AFFAIRS PHARMACISTS

SUMMARY:
A pharmaceutical client is looking for a Senior Regulatory pharmacist to Support 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 a portfolio of product outputs.

POSITION INFO:
Qualifications

Bachelor’s Degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council

Experience

• 5 years’ experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end regulatory activities.
• Good Manufacturing Practices (GMP)
• Pharmaceutical production experience or exposure to supplement regulatory knowledge.

• Experience in use of CTD software builder and compilation of eCTD dossier applications.
• IT skills including Microsoft Office
• Ability to prioritise and work to tight deadlines
• Systems and operations analysis
• Ability to cope with a high degree of complexity and change
• Cross Functional skills: Ability to network, liaise and negotiate with others
• Ability to set standards and objectives and monitor progress
• Complex problem solving and decision-making skill
• Must demonstrate responsibility, excellence and collaboration and align with Company values