Regulatory Affairs Portfolio Lead

3 weeks ago


Midrand, South Africa Jordan HR Full time
Qualifications

  • Bachelors degree in pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
Relevant experience
  • 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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