- Manage work streams for assigned portfolios and report on progress
- Assist internal product queries from departments
- Respond to external product queries from SAHPRA and other stakeholders
- Review regulatory submissions for accuracy, comprehensiveness, and compliance
- Coordinate new product applications in South Africa and other territories
- Develop regulatory strategies and implementation plans for product development and commercialization
- Maintain or enhance regulatory compliance through systems, policies, and procedures
- Bachelor's degree in Pharmacy or Diploma in Pharmacy and registration with the South African Pharmacy Council
- Minimum 5 years' experience in Regulatory Affairs, preferably in human medicines
- Experience with CTD software builder and eCTD applications an advantage
- Strong project management capabilities
- Ability to deliver quality results under tight deadlines
- Professional people management experience
- Leadership skills and personnel resource management
- Prioritization and time management
- Coping with complexity and change
- Cross-functional skills: networking, liaising, and negotiation
- Complex problem-solving and decision-making
- Bachelor's degree in Pharmacy or Diploma in Pharmacy
- 5-10 years
- Degree
-
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Regulatory Affairs Manager - Johannesburg - MVG Recruitment Specialists

2 days ago

Description
About the Role
The Regulatory Affairs Manager will lead the Regulatory team and ensure legal compliance with relevant medicine regulatory authorities, ensuring timely processing of regulatory applications.
Key Responsibilities:
Requirements:
Competencies:
Desired Qualifications:
Desired Work Experience:
Desired Qualification Level:
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Medical Affairs Manager
Staff Unlimited Recruitment Pty Ltd T/A MPC Recruitment Group EC- Johannesburg
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Medical Affairs Manager
Exousia Human Resources- Johannesburg
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Exousia Human Resources- Johannesburg
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medical affairs manager
Watershed Consulting- Johannesburg
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