Senior Regulatory Affairs Pharmacists

QualificationsBachelors Degree in Pharmacy. Diploma in Pharmacy and Registration with the South African Pharmacy CouncilExperience+-5 years experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end regulatory activities. Demonstrable experience across the product development, commercialization and maintenance lifecycleSound project management capabilities Proven ability to consistently deliver to quality, time and cost standardsGood Manufacturing Practices (GMP)Pharmaceutical production experience or exposure to supplement regulatory knowledge.Core competencies Experience in use of CTD software builder and compilation of eCTD dossier applications.IT skills including Microsoft Office, ability to prioritise and work to tight deadlines.Systems and operations analysis, basic cost management skills, active learning and strategic thinking.Cross Functional skills: Ability to network, liaise and negotiate with othersAbility to set standards and objectives and monitor progressComplex problem solving and decision-making skills, customer relationships, development of people.Must demonstrate responsibility, excellence and collaboration and align with company values.Key Job Outputs Manage work streams for- and report on the assigned portfolio of products:Internal product queries from relevant departmentsExternal product queries from the SAHPRA, other MRAs and third party stakeholders.Establish regulatory priorities and allocate resources and workloads Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards