Senior Regulatory Affairs Pharmacist

Industry: PharmaceuticalLocation: MidrandEquity Requirement: EEKey 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.Application Instructions:Apply to response "at" (URL Removed)Subject: MP/SRASupporting documentation required:Comprehensive CV.Copy of Matric Certificate.Copy of Pharmacy Degree.Desired Skills:3 to 5 years' experience in Regulatory Affairs, preferably in human medicines.Desired Work Experience:2 to 5 years.Desired Qualification Level & Accreditations:Degree.South African Pharmacy Council.
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