Regulatory Affairs Manager

About the position

Regulatory Affairs Manager
Industry: Pharmaceutical
Location: JHB
Equity Requirement: EE

Lead the Regulatory team and to 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 timeous processing of regulatory applications.

Key Responsibilities:

• Manage work streams for- and report on the assigned group of portfolios
• Assisting with internal product queries from relevant departments
• Assisting with external product queries from the SAHPRA, other MRA's and third-party stakeholders
• Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
• Co-ordination and submission of new product applications in South Africa and other applicable territories, including but not limited to
• 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. Demonstrated experience across the product development, commercialization and maintenance lifecycle
• Experience in use of CTD software builder and compilation of eCTD application 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

• Experience in use of CTD software builder and compilation of eCTD application will be an advantage.
• Leadership skills, management of personnel resources
• Ability to prioritise 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:

• 5 to 10 years

Desired Qualification Level:

• Degree