Regulatory Affairs Specialist (Pharmaceuticals)

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

Benefits offered by this job

Competitive salary

Health benefits

Remote work options

Professional development

Job summary

Placements24 is seeking a Regulatory Affairs Specialist to support registration and compliance for pharmaceutical products from Pretoria. You will prepare and submit dossiers, liaise with SAHPRA and other authorities, and monitor evolving regulations to ensure market access.

The role requires 4+ years in regulatory affairs, a pharmacy or life sciences background, and strong analytical and communication skills. Flexible working options are available to support work-life balance.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or related field.
• Master’s degree preferred.
• 4+ years of experience in pharmaceutical regulatory affairs.

Responsibilities

• Prepare, review, and submit regulatory submissions to health authorities (CTD, NDA, ANDA).
• Interpret and advise on regulatory requirements for pharmaceutical products.
• Maintain regulatory documentation and ensure compliance with regulations.
• Act as liaison with regulatory agencies and respond to queries.
• Track regulatory changes and assess impact on product portfolio.
• Collaborate with R&D, manufacturing, and commercial teams to align regulatory strategy.

Skills

Regulatory affairs

Pharmaceutical submissions

Regulatory analysis

Communication skills

Education

Bachelor's degree in Pharmacy/ Life Sciences/ related

Master's degree preferred

Tools

Regulatory information management systems

Electronic submission formats

Job description

About the Role

Our client is seeking a knowledgeable and proactive Regulatory Affairs Specialist to support their pharmaceutical product registrations and compliance efforts from Pretoria . This role is critical in ensuring that all company products meet the stringent requirements of health authorities, facilitating market access and maintaining compliance across various territories. You will be responsible for preparing and submitting regulatory dossiers, liaising with regulatory agencies, and staying updated on evolving regulatory landscapes. This is an excellent opportunity to contribute to global health initiatives from the administrative capital of Gauteng .

Key Responsibilities

• Prepare, review, and submit regulatory submissions (e.g., CTD, NDA, ANDA) to health authorities.
• Interpret and advise on regulatory requirements and guidelines relevant to pharmaceutical products.
• Maintain regulatory documentation and ensure compliance with current regulations and standards.
• Serve as a key point of contact with regulatory agencies, responding to queries and requests.
• Track and analyze regulatory changes and assess their impact on the company's product portfolio.
• Collaborate with R&D, manufacturing, and commercial teams to ensure regulatory strategy alignment.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Master's degree preferred.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs.
• Thorough understanding of global regulatory submission processes and requirements (e.g., SAHPRA, FDA, EMA).
• Experience with electronic submission formats and regulatory information management systems.
• Strong analytical and problem‑solving skills with excellent attention to detail.
• Excellent written and verbal communication skills, with the ability to negotiate effectively.

Benefits

• Highly competitive annual salary.
• Comprehensive health and wellness benefits package.
• Flexible working arrangements, including remote work options.
• Professional development opportunities and support for continuing education.
• A challenging and rewarding role contributing to patient access to medicines in Pretoria .