Senior Regulatory Affairs Associate – Clinical Trial Applications

Parexel

Senior Regulatory Affairs Associate ensuring timely performance of regulatory submissions for clinical trials in South Africa. Collaborating with internal stakeholders and regulatory agencies across projects.

Posted 6/4/2026full-timeRemote • 🇿🇦 South AfricaSeniorWebsite

Tech Stack

Tools & technologies

VBA

About the role

Key responsibilities & impact

Ensure timely performance of work within project scope to quality expectations of internal stakeholders and clients
Act as Project Lead or Work Stream Lead
Assure the work of the team is delivered on time and meets clients’ quality expectations
Manage local submissions as Local Regulatory Contact (LRC)
Coordinate regulatory submissions in participating countries as Regulatory Lead
Participate in Regulatory Operations meetings, project team meetings
Maintain relationships with other departments, clients, and regulatory agencies
Involve in local, regional, and/or global projects

Requirements

What you’ll need

University degree in a science discipline
Background in clinical trial management
Initial years of Regulatory Affairs experience working with Clinical Trial Applications in South Africa - must
Experience with clinical trial submissions in other Southern African Countries - preferred
Good level of knowledge of the CTA business
Expertise/skill in cross-functional project management and planning
IT knowledge (Veeva Regulatory and Clinical Vaults - excel – VBA – powerBI)
Solid analysis and synthesis capability
Solution-oriented and problem-solving skills.
Customer-oriented and autonomous
Fluency in English is a must along with the local language.

Benefits

Comp & perks

Health insurance
Flexible working arrangements
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Regulatory AffairsClinical Trial ManagementClinical Trial ApplicationsProject ManagementAnalysisSynthesisProblem SolvingSolution Orientation

Soft Skills

Customer OrientationAutonomyInterpersonal Skills