Regulatory Affairs Pharmacist (North JHB)

MVG Recruitment Specialists; Cape Town; On-site; ZAR 500,000 - 700,000; Full time

Job summary

A leading pharmaceutical recruitment agency is seeking a Regulatory Affairs Operations Pharmacist. You'll oversee regulatory activities, manage submissions, and collaborate with teams. Ideal candidates have a Pharmacy degree and regulatory experience. This full-time position is based in Gauteng and requires strong document management skills.

Qualifications

• Minimum of 2 years Regulatory Operations experience.
• Experience in managing projects and team collaboration.
• Expertise in regulatory submission requirements.
• Strong skills in electronic document preparation and management.
• Experience developing SOPs aligned with health authority requirements.

Responsibilities

• Oversee and guide teams managing electronic submissions.
• Represent Regulatory Operations on project teams.
• Maintain knowledge of regulations from Health Authorities.
• Collaborate with cross-functional teams for document compliance.
• Lead development of processes for regulatory operations.
• Provide training in document management systems.

Skills

Proofreading

Adobe Acrobat

FDA Regulations

Manufacturing & Controls

Biotechnology

Clinical Trials

Research & Development

GLP

cGMP

Product Development

Chemistry

Writing Skills

Education

Bachelor's Degree in Pharmacy

Tools

eCTD publishing systems

Job description

Introduction

Regulatory Affairs Pharmacist (North JHB)

Location: Gauteng

Closing Date: 15 October 2025

Ref: MVG / RAOPS

Email Applications to: response

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

• Bachelors 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

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

To Apply

Submit your CV quoting Ref: MVG / RAOPS to

Closing Date: 15 October 2025

Key Skills

• Proofreading
• Adobe Acrobat
• FDA Regulations
• Manufacturing & Controls
• Biotechnology
• Clinical Trials
• Research & Development
• GLP
• cGMP
• Product Development
• Chemistry
• Writing Skills

Employment Type

Full-Time

Experience

years

Vacancy

1