Senior Regulatory Affairs Lead: Submissions & Compliance

Placements24; Richards Bay; On-site; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Performance bonus

Medical benefits

Retirement benefits

International travel

Job summary

Placements24 is seeking a Senior Regulatory Affairs Specialist to oversee regulatory submissions and compliance for a diverse product portfolio. Based in Richards Bay, KwaZulu-Natal, you will navigate global regulatory landscapes to ensure market approvals and ongoing compliance.

You will lead dossier preparation for SAHPRA, FDA, and EMA, advise on development strategies, and collaborate with R&D, Manufacturing, and Marketing to align regulatory plans. On-site role with competitive benefits.

Qualifications

• Bachelor's degree in a scientific or pharmaceutical discipline; advanced degree preferred.
• Minimum of 6 years in pharmaceutical regulatory affairs.
• Experience with SAHPRA, FDA, EMA submissions.
• Strong communication and negotiation abilities.
• Ability to manage multiple projects in a fast-paced environment.

Responsibilities

• Prepare, review, and submit regulatory dossiers to health authorities (SAHPRA, FDA, EMA).
• Ensure product labeling and promotional materials comply with regulatory requirements.
• Maintain regulatory compliance for approved products throughout their lifecycle.
• Provide strategic regulatory guidance on development and lifecycle management.
• Liaise with regulatory agencies and respond to queries.
• Monitor regulatory changes and advise on impact.
• Support post-approval changes, variations, and renewals.
• Collaborate with R&D, Manufacturing, Marketing to align regulatory plans.
• Develop and implement regulatory processes and training programs.
• Manage regulatory databases and documentation.

Skills

Communication

Negotiation

Analytical thinking

Project management

Independent work

Education

Bachelor's degree in science or pharmacy

Tools

Regulatory information systems

CTD submissions

Job description

Placements24 is seeking a Senior Regulatory Affairs Specialist to oversee regulatory submissions and compliance for a diverse product portfolio. Based in Richards Bay, KwaZulu-Natal, you will navigate global regulatory landscapes to ensure market approvals and ongoing compliance.

You will lead dossier preparation for SAHPRA, FDA, and EMA, advise on development strategies, and collaborate with R&D, Manufacturing, and Marketing to align regulatory plans. On-site role with competitive benefits.