Pharmaceutical Regulatory Affairs Specialist

Placements24; Rustenburg; Hybrid; ZAR 650,000 - 900,000; Full time

Job summary

Placements24 is seeking a Pharmaceutical Regulatory Affairs Specialist to join their client’s team with remote work flexibility and an operational focus near Rustenburg. You will ensure products meet regulatory requirements for market approval and ongoing compliance.

Responsibilities include preparing and submitting regulatory dossiers, liaising with health authorities such as SAHPRA, FDA, and EMA, and coordinating with R&D, Manufacturing, and QA to gather submission data.

Qualifications

• Bachelor's degree in Pharmacy or Life Sciences.
• 4+ years of regulatory affairs experience.
• Experience preparing dossiers for major markets.
• Knowledge of GMP/GCP/GLP principles.

Responsibilities

• Prepare, review, and submit regulatory dossiers for NDAs and variations in global markets.
• Interpret and apply regulatory guidelines from SAHPRA, FDA, and EMA to ensure compliance.
• Liaise with internal departments (R&D, Manufacturing, QA) to gather submission data.
• Monitor regulatory intelligence and advise on regulatory impacts.
• Manage post-approval regulatory activities and lifecycle management.
• Respond to queries from health authorities and support inspections.

Skills

Regulatory affairs

Analytical skills

Communication skills

Independent work

Education

Bachelor's degree in Pharmacy or Life Sciences

Master's degree (a plus)

Job description

About the Role

Our client is actively seeking a dedicated Pharmaceutical Regulatory Affairs Specialist to join their dynamic team, offering the flexibility of remote work, with a base operational focus near Rustenburg . This role is vital for ensuring that all pharmaceutical products meet stringent regulatory requirements for market approval and continued compliance. You will be responsible for preparing and submitting regulatory dossiers, liaising with health authorities, and staying abreast of evolving regulations. The ideal candidate possesses exceptional analytical skills, a thorough understanding of global regulatory landscapes, and the ability to navigate complex compliance requirements, ensuring our client's products reach patients safely and efficiently.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers for new drug applications (NDAs) and variations in various global markets.
• Interpret and apply regulatory guidelines from agencies such as SAHPRA, FDA, and EMA to ensure product compliance.
• Liaise with internal departments (e.g., R&D, Manufacturing, Quality Assurance) to gather necessary information for submissions.
• Monitor regulatory intelligence, track changes in regulations, and advise the business on potential impacts.
• Manage post-approval regulatory activities, including annual reports and lifecycle management.
• Respond to queries from health authorities and facilitate regulatory inspections.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, or a related discipline.
• A Master's degree is a plus.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs .
• Proven experience in preparing and submitting dossiers for major markets.
• Strong understanding of drug development processes and GMP/GCP/GLP principles.
• Excellent written and verbal communication skills, with meticulous attention to detail.
• Ability to work independently and manage multiple projects effectively in a remote setting.

Benefits

• Competitive salary and performance-based incentives.
• Comprehensive medical aid and life insurance coverage.
• Generous annual leave and flexible working hours.
• Significant opportunities for career growth and professional development in regulatory affairs .
• A fully remote working arrangement, providing work-life balance.