Pharmaceutical Regulatory Affairs Associate

Placements24; LegKraal Gate; On-site; ZAR 180,000 - 300,000; Full time

Benefits offered by this job

Medical aid benefits

Retirement fund contributions

Paid annual leave

Job summary

Placements24 is seeking a motivated Regulatory Affairs Associate to support our fast-growing pharmaceutical client in Mahikeng, North West. You will assist in regulatory dossiers preparation, maintain documentation, and liaise with authorities.

This entry-level to early-career role offers exposure to regulatory submission processes, cGMP awareness, and cross-functional collaboration with R&D, QA, and Production.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• 1–3 years of experience in regulatory affairs within the pharmaceutical industry.
• Understanding of regulatory submission processes in South Africa.
• Strong organizational and detail-oriented skills.
• Good written and verbal communication skills.
• Proficient in Microsoft Office Suite.
• Legally authorized to work in South Africa.

Responsibilities

• Assist in preparation, compilation, and submission of regulatory dossiers to health authorities.
• Maintain and update regulatory documentation with accuracy.
• Track regulatory submission status and follow up on queries.
• Review product labeling and promotional materials for compliance.
• Ensure compliance with cGMP and other relevant regulations.
• Conduct literature searches and stay updated on regulatory guidelines.
• Coordinate with R&D, Quality, and Production for submissions.
• Support registration and lifecycle management of pharmaceutical products.
• Communicate with regulatory agencies as directed.

Skills

Regulatory affairs

Regulatory submissions

Attention to detail

Communication

Education

Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or related field

Tools

Microsoft Office

Job description

About the Role

Our client, a rapidly expanding pharmaceutical company, is seeking a motivated Regulatory Affairs Associate to support their operations in **Mahikeng, North West**. This role is integral to ensuring that all pharmaceutical products comply with national and international regulatory standards. You will assist in the preparation and submission of regulatory dossiers, maintain regulatory documentation, and liaise with regulatory authorities. The ideal candidate will have a solid understanding of regulatory principles and a keen eye for detail. This is a fantastic opportunity for an early-career professional to gain valuable experience in the pharmaceutical regulatory field within the growing region of **Mahikeng, North West**.

Key Responsibilities

• Assist in the preparation, compilation, and submission of regulatory dossiers to health authorities.
• Maintain and update regulatory documentation, ensuring accuracy and completeness.
• Track regulatory submission status and follow up on outstanding queries.
• Support the review of product labeling and promotional materials for compliance.
• Assist in ensuring compliance with current Good Manufacturing Practices (cGMP) and other relevant regulations.
• Conduct literature searches and stay informed about regulatory guidelines and changes.
• Coordinate with internal departments (e.g., R&D, Quality, Production) to gather necessary information for submissions.
• Support the registration and lifecycle management of pharmaceutical products.
• Communicate with regulatory agencies as directed.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• 1-3 years of experience in regulatory affairs or a related field within the pharmaceutical industry, preferably in **Mahikeng, North West**.
• Basic understanding of regulatory submission processes and requirements in **South Africa**.
• Strong organizational skills and meticulous attention to detail.
• Good written and verbal communication skills.
• Ability to manage multiple tasks and work effectively under pressure.
• Proficiency in Microsoft Office Suite.
• Proactive attitude and willingness to learn.
• Must be legally authorized to work in **South Africa**.

Benefits

This position offers a competitive entry-level salary, medical aid benefits, and retirement fund contributions. Employees are entitled to paid annual leave and opportunities for training and professional development in regulatory affairs. The work environment in **Mahikeng, North West** is dynamic and supportive, providing a solid foundation for career growth within the pharmaceutical industry. Join our client's dedicated team and contribute to bringing essential medicines to patients.