Regulatory Affairs Consultant (South Africa) at PAREXEL

You will operate as a regulatory operational Subject Matter Expert for CTAs in South Africa and other African countries and drive timely delivery of submissions in the region

Role Responsibilities

• Performs submission management activities for assigned protocols. Partners with study teams, is responsible for managing the required regulatory activities and CTA submission delivery in multiple countries
• Acts as Regulatory SME for CTAs for South Africa and other countries in the region
• Advises on submission strategy for the region and assess the associated impact of submission delivery activities in the region and leads/attends relevant meetings to advocate realistic deliverable timelines and strategy
• Liaises with Core team, SSU and Study Management, regarding the needed documentation
• Prepares, reviews and submits CTAs to Health Authorities in South Africa and other African countries in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct
• Ensures high quality submissions are performed, compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines
• Escalates, informs, and resolves any issues that may impact submission builds or the logistics of submission delivery across the region

Skills And Experience

• BS/BSc in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
• Experience in Regulatory Affairs and Clinical Research (5+ years)
• In-depth understanding and proven execution of CTA processes in South Africa, Ghana, Kenya Mauritius, Nigeria and Uganda
• Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
• Fluency in English is a must (any additional European languages are a plus)