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Regulatory Affairs Associate
Parexel International Corporation
South Africa, Remote
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.We are currently looking for two Regulatory Affairs Consultants in South Africa (Home or Office based) who will be accountable for operational submission execution for designated CTAs.
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)
You will be rewarded with a competitive salary and benefits package! And we can offer extensive career development within our growing Regulatory portfolio.
Job posted: 2023-02-07