Senior Regulatory Affairs Associate - CTA

We are recruiting for a Senior Regulatory Affairs Associate in South Africa. As part of a multi-national project team, you will take the lead to coordinate the compilation, review and submission of regulatory agency applications for international clinical trials in compliance with international regulatory requirements as well as internal and client standard operating procedures (SOPs). Your knowledge of clinical trial regulations will enable you to support the sponsor for the development of optimized clinical trial submission strategies. Having knowledge and experience on (EU) Marketing Authorization Application procedures would be advantageous.

Scope of responsibilities:

• To prepare and coordinate of regulatory deliverables for assigned projects in South Africa and other countries, including close cooperation with regulatory authorities

• To act as local regulatory contact and regulatory lead for assigned studies

• Preparing, reviewing and compiling regulatory CTA applications, amendments, and end of trial notifications.

• Working under the general direction of the Regulatory & Access Manager/Project Manager, taking responsibility for ensuring that the client work is performed and delivered on time

• Maintain a working knowledge of, and ensure compliance with, applicable ICH Guidelines, GCP, Regulatory Agency requirements and internal SOPs

• Preparation and review of drug labels to ensure compliant

• May prepare and/ or deliver presentation with the support of senior colleagues Qualifications

Ideal candidate will possess:

• Few years of experience in Regulatory Affairs and Clinical Research in Pharma or CRO.

• A degree in a science discipline. Advanced degree will be an asset.

• Fluency in English is a must along with the local language.

• Experience in clinical study start-up.

• Ability to work with a multinational team, focusing on multiple issues under tight timelines.

• Good Computer skills.