Senior Regulatory Affairs Associate (MAAs)

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 Associate to 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)