When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
We are seeking a highly motivated Senior 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 p ost 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)
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.
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