Regulatory Affairs Specialist - Pharmaceutical Submissions

Placements24; Gauteng; On-site; ZAR 700,000 - 950,000; Full time

Benefits offered by this job

Health insurance

Retirement contributions

Professional development opportunities

Job summary

Placements24 is seeking a Regulatory Affairs Specialist based in Tembisa, Gauteng to manage regulatory submissions and ensure compliance with SAHPRA and international requirements. The role involves close collaboration with R&D, Manufacturing, and Marketing to support product registrations and lifecycle management.

The ideal candidate has a strong background in pharmaceutical regulatory affairs, excellent communication skills, and a meticulous approach to documentation to help drive timely

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry or related field required.
• Minimum 5 years of pharmaceutical regulatory affairs experience.
• Experience preparing and submitting regulatory dossiers to health authorities.
• Strong knowledge of SAHPRA and international regulatory requirements.
• Excellent written and verbal communication with meticulous attention to detail.
• Proficiency with regulatory information management systems is an advantage.

Responsibilities

• Prepare, compile, and submit regulatory dossiers for NDAs, variations, and renewals.
• Ensure submissions comply with local and international guidelines (SAHPRA, FDA, EMA).
• Liaise with regulatory authorities to respond to queries and facilitate approvals.
• Monitor regulatory landscape and assess impact on products and strategies.
• Review product labeling, promotional materials, and advertising for compliance.
• Maintain regulatory databases and ensure documentation is up-to-date.
• Collaborate with R&D, Manufacturing, and Marketing to gather submission information.
• Provide regulatory guidance and support to cross-functional teams.
• Manage post-approval commitments and lifecycle management activities.

Skills

Regulatory submissions

Documentation accuracy

Stakeholder communication

Regulatory knowledge

Project management

Analytical skills

Education

Bachelor's degree in Pharmacy

Bachelor's degree in Life Sciences

Bachelor's degree in Chemistry

Master's degree

Tools

Regulatory information systems

Job description

About the Role

Our client, a globally recognized pharmaceutical organization, is seeking a skilled Regulatory Affairs Specialist to join their dedicated team. This key position is based in **Tembisa, Gauteng**, and will be responsible for managing pharmaceutical product registrations and ensuring compliance with national and international regulatory requirements. The ideal candidate will possess a comprehensive understanding of regulatory submission processes and a meticulous approach to documentation. This role offers a unique chance to contribute to the company's global expansion by ensuring timely access to essential medicines for patients. You will be an integral part of a professional team committed to maintaining the highest standards of regulatory compliance and product integrity.

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers for new drug applications (NDAs), variations, and renewals.
• Ensure all regulatory submissions are accurate, complete, and compliant with local and international guidelines (e.g., SAHPRA, FDA, EMA).
• Liaise with regulatory authorities to respond to queries and facilitate the approval process.
• Monitor changes in the regulatory landscape and assess their impact on company products and strategies.
• Review product labeling, promotional materials, and advertising for regulatory compliance.
• Maintain regulatory databases and ensure all documentation is up-to-date.
• Collaborate with internal departments (e.g., R&D, Manufacturing, Marketing) to gather necessary information for submissions.
• Provide regulatory guidance and support to cross‑functional teams.
• Manage post‑approval commitments and lifecycle management activities.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field. A Master's degree is a plus.
• Minimum of 5 years of experience in pharmaceutical regulatory affairs.
• Demonstrated experience in preparing and submitting regulatory dossiers to health authorities.
• In-depth knowledge of regulatory requirements in South Africa and key international markets.
• Excellent understanding of the drug development and manufacturing process.
• Strong analytical and problem‑solving skills, with meticulous attention to detail.
• Exceptional written and verbal communication skills.
• Proficiency in regulatory information management systems is advantageous.
• Ability to manage multiple projects and meet tight deadlines.

Benefits

Our client offers a competitive salary and a comprehensive benefits package, including health insurance, retirement contributions, and opportunities for professional development. This role provides a significant opportunity to influence regulatory strategies and ensure patient access to vital medications. You will be part of a supportive and dynamic team in **Tembisa, Gauteng**, contributing to the company's mission of improving global health. We value expertise and dedication, offering a career path with substantial growth potential.