Pharmaceutical Regulatory Affairs Associate

Placements24; Benoni; On-site; ZAR 300,000 - 600,000; Full time

Benefits offered by this job

Competitive starting salary

Medical aid

Provident fund

Paid time off

Professional development opportunities

Job summary

Placements24 seeks a diligent Pharmaceutical Regulatory Affairs Associate in Benoni to support regulatory submissions and registrations. You will collaborate with R&D, Quality, and Marketing to ensure compliance and timely approvals for medicines.

Ideal candidates have a life science degree and 1–3 years in regulatory affairs, with strong attention to detail and communication skills. The role offers growth in a fast-paced pharma environment in Benoni.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology or related life science.
• 1–3 years of experience in pharmaceutical regulatory affairs or related field.
• Basic understanding of regulatory requirements (ICH guidance).
• Strong organizational and communication skills.

Responsibilities

• Assist in preparation, assembly, and review of regulatory submission documents.
• Support maintenance of product registrations and filings across global markets.
• Conduct regulatory literature searches and gather regulatory intelligence.
• Coordinate responses to regulatory agency queries.
• Review labeling, advertising, and promotional materials for compliance.
• Support post-approval commitments and regulatory databases.
• Collaborate with R&D, Quality, and Marketing on regulatory matters.
• Participate in project team meetings and regulatory strategy discussions.
• Support review of technical documentation and validation reports.

Skills

Regulatory knowledge

Attention to detail

Communication skills

Teamwork

Learning mindset

Education

Bachelor's degree in Pharmacy, Chemistry, Biology or related life science

Tools

Microsoft Office

Regulatory databases

Job description

About the Role

Our client, a rapidly growing pharmaceutical company committed to developing innovative therapies, is seeking a diligent and motivated Pharmaceutical Regulatory Affairs Associate to join their team in Benoni . This role offers an excellent opportunity for an early-career professional to gain broad experience in regulatory affairs within the pharmaceutical industry. You will support the preparation and submission of regulatory documents, assist in maintaining product registrations, and contribute to ensuring compliance with global regulatory requirements. The ideal candidate will possess a strong foundational knowledge of pharmaceutical regulations, exceptional attention to detail, and excellent organizational and communication skills. We are looking for an enthusiastic individual eager to learn and grow within a supportive and dynamic environment. This position is crucial in facilitating the timely approval and availability of our client's vital medicines, contributing directly to patient access and healthcare outcomes.

Key Responsibilities

• Assist in the preparation, assembly, and review of regulatory submission documents (e.g., supplements, annual reports, amendments).


• Support the maintenance of product registrations and regulatory filings in various global markets.


• Conduct literature searches and regulatory intelligence gathering to stay informed of evolving regulations.


• Help coordinate responses to regulatory agency queries.


• Review labeling, advertising, and promotional materials for compliance with applicable regulations.


• Assist in ensuring compliance with post-approval commitments.


• Maintain regulatory databases and filing systems.


• Collaborate with internal departments (e.g., R&D, Quality, Marketing) on regulatory matters.


• Participate in project team meetings and contribute to regulatory strategy discussions.


• Support the regulatory review of technical documentation and validation reports.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline.


• 1-3 years of experience in pharmaceutical regulatory affairs or a related field (e.g., Quality Assurance, R&D).


• Basic understanding of pharmaceutical regulatory requirements and guidelines (e.g., ICH).


• Strong organizational skills and meticulous attention to detail.


• Excellent written and verbal communication skills.


• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).


• Ability to work independently and as part of a team.


• Eagerness to learn and adapt to changing regulatory environments.


• Experience with regulatory submission software or databases is a plus.


• Strong analytical and problem-solving capabilities.

Benefits

• Our client offers a competitive starting salary, commensurate with experience and qualifications, along with potential for annual bonuses.


• Comprehensive benefits package including medical aid, provident fund, and paid time off.


• Excellent opportunities for professional development, including on-the-job training, internal workshops, and support for external regulatory courses.


• The work environment in Benoni is fast-paced, collaborative, and focused on innovation and growth.


• Contribute to bringing essential medicines to patients while developing a robust career in regulatory affairs.


• A positive and supportive company culture fosters employee engagement and well-being.