MIDRAND
Salary: R1M
Reporting to: Regulatory Affairs Manager
Job Overview
Support the Regulatory Affairs 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. To ensure 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 timeous processing of regulatory applications.
Requirements
- Bachelors degree in pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
- 3 to 5 years experience in Regulatory Affairs, preferably in human medicines
- Demonstrable experience across the product development, commercialization and maintenance lifecycle
- Sound project management capabilities
- Proven ability to consistently deliver to quality, time and cost standards
- Experience in use of CTD software builder and compilation of eCTD applications.
- IT skills
- Ability to prioritise 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
- Must demonstrate responsibility, excellence and collaboration and align with Company values
To apply for this role, please forward CVs to ;and use POS25036 REGULATORY AFFAIRS PORTFOLIO LEAD in the subject line.
