Regulatory Affairs Manager

Jordan HR • Other • Midrand, South Africa • 8h ago

Qualifications

Bachelors degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council

Relevant experience

Minimum of 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 application will be an advantage.
IT skills
Leadership skills, management of personnel resources
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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