Senior Regulatory Affairs Specialist
2 months ago
Job Requirements:
For the position of Senior Regulatory Affairs Specialist at Jordan HR, we are seeking a highly skilled and experienced professional in the field of regulatory affairs. The ideal candidate will have a strong background in human medicines, including complementary medicines and medical devices, with a minimum of 5 years of experience in end-to-end regulatory activities.
Key Responsibilities:
- Compilation of eCTD dossier applications using CTD software builder
- Good Manufacturing Practices (GMP) and pharmaceutical production experience
- Ability to prioritize and work to tight deadlines, with excellent IT skills including Microsoft Office
- Systems and operations analysis, complex problem-solving, and decision-making skills
- Ability to network, liaise, and negotiate with others, with a strong focus on responsibility, excellence, and collaboration
Qualifications:
- Bachelor's Degree in Pharmacy or Diploma in Pharmacy and registration with the South African Pharmacy Council
Core Competencies:
- Experience in use of CTD software builder and compilation of eCTD dossier applications
- IT skills including Microsoft Office
- Ability to prioritize and work to tight deadlines
- Systems and operations analysis
- 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 skill
- Must demonstrate responsibility, excellence, and collaboration and align with Company values
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