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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Senior Regulatory Affairs Associate (MAAs)
Job ID R0000039697 , South AfricaWe are seeking a highly motivatedSenior Regulatory Affairs Associateto join our dynamic team. This role offers an exciting opportunity to work on post authorization regulatory submissions for the South African Health Products Regulatory Authority (SAHPRA), ensuring compliance with local requirements while contributing to the delivery of critical healthcare solutions.
As a Senior Regulatory Affairs Associate, you will work both independently and collaboratively within project teams, taking ownership of regulatory submissions from assessment through to Health Authority filing.
The role can be home or office based.
Key Responsibilities
Review and assess regulatory changes to confirm scope, impact, and submission requirements
Determine appropriate submission types in accordance with SAHPRA guidelines for CMC and Safety changes
Plan submissions by creating or confirming Submission Content Plans and required Submission Components
Request additional documents as required by Health Authorities
Compile and author local documents using approved templates and naming conventions
Complete all required internal reviews and approvals
Ensure Submission Content Plans reach approved state with all required documents included
Request necessary payments and coordinate publishing to enable Health Authority submission
Required Skills and Qualifications:
University Degree in a Scientific or Technical Discipline
Several years of experience in an industry-related environment
Knowledge of post authorization regulatory submission processes and requirements
Familiarity with SAHPRA guidelines
Awareness of CMC and Safety regulatory requirements
Strong teamwork and collaboration skills
Excellent interpersonal and intercultural communication skills, both written and verbal
Proficiency in English (written and spoken)
#LI-REMOTE
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