Regulatory Affairs Specialist - Pharmaceutical Submissions

Placements24; LegKraal Gate; On-site; ZAR 480,000 - 720,000; Full time

Benefits offered by this job

Medical aid

Pension fund

Paid time off

Professional development

Job summary

Placements24 is seeking a Regulatory Affairs Specialist in Mahikeng, North West, to ensure regulatory compliance for drug registrations. You will prepare, review, and submit CTD dossiers, liaise with SAHPRA, and guide internal teams on regulatory expectations.

With 3–5 years of pharmaceutical regulatory experience and strong attention to detail, you will monitor changes, manage submissions, and support inspections while collaborating across R&D, manufacturing, and marketing.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
• A Master's degree is advantageous.
• 3–5 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of SA regulations and submission requirements.
• Familiarity with ICH guidelines is a plus.
• Proven experience in preparing and submitting regulatory dossiers.
• Strong analytical and problem-solving skills with attention to detail.
• Excellent written and verbal communication skills.
• Ability to manage multiple projects and meet deadlines.
• Proficiency in regulatory information management systems and standard office software.

Responsibilities

• Prepare, review, and submit regulatory dossiers (CTD) for registrations and post-approval changes.
• Liaise with regulatory agencies (e.g., SAHPRA) to facilitate reviews.
• Ensure submissions comply with guidelines and policies.
• Manage lifecycle of approvals, including renewals and amendments.
• Provide regulatory guidance to R&D, manufacturing, and marketing.
• Monitor regulatory changes and assess impact on products and processes.
• Maintain regulatory databases and document management systems.
• Contribute to regulatory strategies for new product development.
• Support regulatory inspections and audits.
• Review labeling and promotional materials for compliance.

Skills

Regulatory submissions

Attention to detail

Written and verbal communication

Project management

Time management

Education

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

Master's degree advantageous

Tools

Regulatory information management systems

Office software proficiency

Job description

About the Role

Our client, a growing pharmaceutical company dedicated to bringing essential medicines to market, is seeking a detail-oriented and experienced Regulatory Affairs Specialist. This role is vital for ensuring that pharmaceutical products meet all regulatory requirements for approval and marketing in various jurisdictions. You will be responsible for preparing, submitting, and maintaining regulatory documentation for new drug applications (NDAs), variations, and renewals. This position is based in Mahikeng, North West , a developing region focused on enhancing its industrial and healthcare infrastructure. The ideal candidate will have a strong understanding of regulatory frameworks and a proven ability to navigate complex submission processes within the pharmaceutical industry. This is an excellent opportunity to contribute to public health by facilitating access to safe and effective medicines.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD format) for new product registrations and post-approval changes.
• Liaise with regulatory agencies (e.g., SAHPRA) to facilitate the review and approval process.
• Ensure all regulatory submissions comply with current guidelines and company policies.
• Manage the lifecycle of regulatory approvals, including renewals and amendments.
• Provide regulatory guidance and support to internal teams, including R&D, manufacturing, and marketing.
• Monitor changes in regulatory requirements and assess their impact on company products and processes.
• Maintain regulatory databases and document management systems.
• Contribute to the development of regulatory strategies for new product development.
• Support regulatory inspections and audits.
• Review labeling and promotional materials for regulatory compliance.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
• A Master's degree is advantageous.
• Minimum of 3-5 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of South African pharmaceutical regulations and regulatory submission requirements.
• Familiarity with international regulatory guidelines (e.g., ICH) is a plus.
• Proven experience in preparing and submitting regulatory dossiers.
• Strong analytical and problem-solving skills with exceptional attention to detail.
• Excellent written and verbal communication skills.
• Ability to manage multiple projects and meet tight deadlines.
• Proficiency in regulatory information management systems and standard office software.

Benefits

• Our client offers a competitive salary, performance incentives, and a comprehensive benefits package including medical aid, pension fund, and paid time off.
• Opportunities for professional development, including training and conference attendance, are provided.
• The company fosters a collaborative and growth-oriented work environment.