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Midrand: Senior Regulatory Affairs Pharmacists posted by Jordan Human Resources






Date 2024-06-24
Job Title Senior Regulatory Affairs Pharmacists
Employer Jordan Human Resources
More Information
Salary 800000
Category Medical
Location Gauteng
/ Midrand

Job Summary

Qualifications

Bachelor’s Degree in Pharmacy. Diploma in Pharmacy and Registration with the South African Pharmacy Council

Experience

  • +-5 years’ experience in Regulatory Affairs, preferably in human 
  • medicines, including complementary medicines and medical devices for end-to-end regulatory activities. 
  • 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
  • Good Manufacturing Practices (GMP)
  • Pharmaceutical production experience or exposure to supplement 
  • regulatory knowledge.

Core competencies

  • Experience in use of CTD software builder and compilation of eCTD dossier applications.
  • IT skills including Microsoft Office, ability to prioritise and work to tight deadlines.
  • Systems and operations analysis, basic cost management skills, active learning and strategic thinking.
  • 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.


Key Job Outputs

Manage work streams for- and report on the assigned portfolio of products:

  • Internal product queries from relevant departments
  • External product queries from the SAHPRA, other MRA’s and third party stakeholders.
  • Establish regulatory priorities and allocate resources and workloads
  •  Review regulatory agency submission of materials to ensure timelines, 
  • accuracy, comprehensiveness, or compliance with regulatory 
  • standards
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Senior Regulatory Affairs Pharmacists position available in Gauteng, Midrand. This job position was posted by Jordan Human Resources. The job has been posted as a char8000 ad on 2024-06-24 at 01:05:11 in the Medical category

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