Job Description

Regulatory Affairs Pharmacist (North JHB)
Location: Gauteng
Closing Date: 15 October 2025
Ref: MVG/RAOPS
Email Applications to: response@mvgrecruitment.co.za
Position Overview
MVG Recruitment Specialists is seeking a Regulatory Affairs Operations Pharmacist on behalf of a leading pharmaceutical company within their OTC division. The successful candidate will oversee Regulatory Operations activities and strategic initiatives supporting pre- and post-approval filings and document maintenance.
This pivotal role involves the supervision and coordination of document formatting, compilation, and submission processes to both local and international regulatory authorities. The ideal candidate will be an experienced professional capable of managing multi-disciplinary project teams, driving submission timelines, and implementing efficient regulatory systems and technologies.
Key Responsibilities

• Oversee and guide teams managing the creation, assembly, and publishing of electronic submissions, including New Product Applications and Life Cycle Amendments.
• Represent Regulatory Operations on project teams, ensuring adherence to timelines and deliverables.
• Maintain up-to-date knowledge of regulations and documentation requirements from Health Authorities and ICH.
• Collaborate with cross-functional teams (clinical, quality, regulatory) to ensure document compliance with internal and external standards.
• Lead the development and refinement of processes, SOPs, and work instructions for regulatory systems and operations.
• Provide training and mentorship to team members in document management and submission systems.

Qualifications & Experience

• Bachelor's Degree in Pharmacy with a minimum of 2 years' Regulatory Operations experience
• Proven experience in managing projects, timelines, and team collaboration
• Expertise in document management systems, eCTD format, regulatory submission requirements, and eCTD publishing systems
• Strong technical skills in electronic document preparation, submission, and life cycle management
• Experience developing SOPs and work instructions aligned with health authority requirements

Core Competencies

• Advanced technical and analytical skills for regulatory document management
• Strong leadership, problem-solving, and organizational abilities
• Excellent written and verbal communication skills
• Proven relationship-building and negotiation skills
• Intermediate to Advanced Proficiency in Excel and Adobe Acrobat
• Ability to thrive in a high-intensity, deadline-driven environment

? To Apply:
Submit your CV quoting Ref: MVG/RAOPS to response@mvgrecruitment.co.za
Closing Date: 15 October 2025

Skills Required