# Regulatory Affairs Pharmacist

**Company**: GSK
**Location**: Johannesburg
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/Johannesburg-West-Street/Regulatory-Affairs-Pharmacist_449793?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_2cfd3f10-64d

## Description

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives.

As a Regulatory Affairs Pharmacist based in South Africa, you will play a vital role in ensuring our products meet all regulatory requirements. You will collaborate with diverse teams, acting as a key partner in navigating regulations and accelerating product approvals.

**Responsibilities:**

- Prepare and submit regulatory dossiers and applications to support product approvals and market access in South Africa.

- Ensure ongoing regulatory compliance for products by monitoring changes in regulations and updating documentation accordingly.

- Collaborate closely with cross-functional teams including marketing, supply chain, quality, and medical affairs to align regulatory requirements with business needs.

- Lead the review and approval process for product labelling and promotional materials to ensure compliance with local regulations and company policies.

- Build and maintain strong relationships with regulatory authorities and external partners to support successful product registrations and issue resolution.

- Contribute to improving regulatory processes and sharing insights that support faster, more efficient product launches and lifecycle management.

**Requirements:**

- Bachelor of Pharmacy (BPharm) degree or equivalent qualification in pharmacy.

- Registration as a Pharmacist with the South African Pharmacy Council (SAPC) or relevant professional body.

- At least 3-5 years of experience in Regulatory Affairs or a related function within the pharmaceutical or healthcare industry.

- Solid understanding of South African Medicines and Related Substances Act and applicable regulatory frameworks.

- Strong attention to detail and ability to interpret and apply complex regulatory information clearly.

- Excellent communication skills, with the ability to influence and build effective working relationships across functions and with external agencies.

**Preferred Qualifications:**

- Experience working within pharmaceutical regulatory affairs in South Africa.

- Knowledge of dossier preparation for product registrations, variations, and renewals under current local regulations.

- Familiarity with labelling requirements and advertising codes for pharmaceutical products.

- Proven project management skills and ability to handle multiple priorities with a structured approach.

- Additional qualifications such as a Master’s degree in Regulatory Affairs, Pharmacy, or a related field.

- Experience using electronic regulatory submission systems and regulatory intelligence tools.

This is a hybrid position based in Johannesburg, South Africa, offering the chance to work closely with local and regional teams while engaging in cross-functional collaboration.

## Skills

### Required
- Pharmaceutical Regulatory Compliance
- Stakeholder Management
- Communication
- Digital Fluency
- Matrix Leadership

### Nice to have
- Project Management
- Dossier Preparation
- Labelling Requirements
- Advertising Codes
- Electronic Regulatory Submission Systems

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Source: [Apply at gsk.wd5.myworkdayjobs.com](https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/Johannesburg-West-Street/Regulatory-Affairs-Pharmacist_449793?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)