Regulatory Affairs Portfolio Lead
3 weeks ago
- 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.
Core competencies
- 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
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