Senior RA Pharmacist – Midrand
Senior Regulatory Affairs Pharmacist
Industry: Pharmaceutical
Location: Midrand
Equity Requirement: EE
Key Responsibilities:
- Manage work streams for- and report on the assigned portfolio of products
- Conduct dossier due diligence to ensure all data gaps are addressed
- Work in collaboration with internal and external stakeholders to assess regulator’s submissions requirements
- Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
- Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders
- 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
- 3 to 5 years’ experience in Regulatory Affairs, preferably in human medicines
- 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
- Experience in use of CTD software builder and compilation of eCTD applications.
Key Competencies
- Ability to cope with a high degree of complexity and change
- Ability to network, liaise and negotiate with others
- Ability to set standards and objectives and monitor progress
- Complex problem solving and decision-making skills
- Development of people
(Full role profile available on application)
Apply to response@mvgrecruitment.co.za Subject: MP/SRA
Supporting documentation required:
- Comprehensive CV
- Copy of Matric Certificate
- Copy of Pharmacy Degree