Regulatory Affairs Manager
MVG Recruitment Specialists
- Undisclosed
- Permanent Specialist EE position
- Johannesburg
- Posted 27 Nov 2023 by MVG Recruitment Specialists
- Expires in 33 days
- Job 2546841 - Ref MP/RAM
About the position
Regulatory Affairs Manager
Industry: Pharmaceutical
Location: JHB
Equity Requirement: EE
Lead the Regulatory team and ensure legal compliance with the relevant medicine Regulatory Authorities (Country Specific where applicable), Medicines and Related Substances Control Act, and South African Pharmacy Council, ensuring timely processing of regulatory applications.
Key Responsibilities:
- Manage work streams for and report on the assigned group of portfolios
- Assist with internal product queries from relevant departments
- Assist with external product queries from the SAHPRA, other MRAs, and third-party stakeholders
- Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
- Coordinate and submit new product applications in South Africa and other applicable territories
- Develop regulatory strategies and implementation plans for the preparation and submission of new products
- Formulate or implement regulatory affairs systems, policies, and procedures to ensure that regulatory compliance is maintained or enhanced.
Key Requirements:
- Bachelor's degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
- Minimum of 5 years' experience in Regulatory Affairs, preferably in human medicines, with demonstrated experience across the product development, commercialization, and maintenance lifecycle
- Experience in use of CTD software builder and compilation of eCTD applications will be an advantage
- Sound project management capabilities
- Proven ability to consistently deliver to quality, time, and cost standards
- Professional people management experience
Key Competencies:
- Leadership skills and management of personnel resources
- Ability to prioritize and work to tight deadlines
- Ability to cope with a high degree of complexity and change
- Cross-functional skills: Ability to network, liaise, and negotiate with others
- Complex problem-solving and decision-making skills
(Full role profile available on application)
Apply to (Email Address Removed) Subject: MP/RAM
Supporting documentation required:
- Comprehensive CV
- Copy of Matric Certificate
- Copy of Pharmacy Degree
- Copy of Industry Body Registration (SAPC)
Desired Skills:
- Bachelor's degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
Desired Work Experience:
Desired Qualification Level:
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