Remote Pharmaceutical Regulatory Affairs Expert

Placements24; Gqeberha; Hybrid; ZAR 700,000 - 1,100,000; Full time

Benefits offered by this job

Medical benefits

Retirement plan

Remote work flexibility

Professional development

Job summary

Placements24 is seeking a proactive Pharmaceutical Regulatory Affairs Specialist, ideally based in or near Port Elizabeth, with remote work flexibility. You will prepare and submit regulatory dossiers (CTD/ANDA), liaise with health authorities, and guide products through lifecycle compliance to achieve timely market access.

The role requires a Bachelor’s in Pharmacy or related field and 4+ years in Regulatory Affairs, with experience in electronic submissions and regulatory information systems.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry or related field.
• Minimum 4 years of experience in pharmaceutical Regulatory Affairs.
• Strong understanding of regulatory submission processes and guidelines in key markets.
• Experience with electronic submission formats and regulatory information management systems.
• Excellent written and verbal communication, with strong attention to detail.
• Ability to work independently in a remote setting and manage multiple projects.

Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD, ANDA) to health authorities such as SAHPRA.
• Ensure compliance with all applicable regulatory requirements and guidelines throughout the product lifecycle.
• Communicate effectively with regulatory agencies, responding to queries and addressing concerns.
• Monitor changes in the regulatory environment and assess their impact on company products and strategies.
• Collaborate with R&D, manufacturing, and marketing teams to provide regulatory guidance and support.
• Maintain regulatory documentation and databases, ensuring accuracy and completeness.

Skills

Regulatory affairs

Regulatory submissions

Communication

Remote work

Education

Bachelor's degree in Pharmacy/Life Sciences/Chemistry

Tools

Regulatory submissions software

Job description

Placements24 is seeking a proactive Pharmaceutical Regulatory Affairs Specialist, ideally based in or near Port Elizabeth, with remote work flexibility. You will prepare and submit regulatory dossiers (CTD/ANDA), liaise with health authorities, and guide products through lifecycle compliance to achieve timely market access.

The role requires a Bachelor’s in Pharmacy or related field and 4+ years in Regulatory Affairs, with experience in electronic submissions and regulatory information systems.