Pharmaceutical à United States

A pharmaceutical client is looking for a Regulatory Affairs Portfolio Lead to support the Regulatory Affairs team in providing 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. This role ensures legal and regulatory compliance with the relevant medicine regulatory authorities (country-specific where applicable), Medicines and Related Substances Control Act, and South African Pharmacy Council, ensuring timely processing of regulatory applications.

• Bachelor’s degree in pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council

• 3 years’ experience in Regulatory Affairs, preferably in human medicines with experience across product development, commercialization, and maintenance lifecycle
• Experience in quality driven processes such as risk management, change control, deviations, CAPA’s, and root cause investigations
• Additional experience in African territories is preferable.

• Experience in use of CTD software builder and compilation of eCTD applications
• IT skills
• Ability to prioritize and work to tight deadlines
• Systems and operations analysis
• Basic cost management skills
• Active learning
• Strategic thinking
• 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 skills
• Customer relationships
• Development of people

• CTD
• IT Skills
• Regulatory Affairs
• Portfolio Lead