I contribute to clinical research with expertise and empathy. And I do it
Senior Regulatory Affairs Associate (MAAs)
Primary Location: South Africa, Remote Job ID R0000039697 Category Regulatory Affairs Date Posted 03/12/2026Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
We 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)
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