Hybrid Pharma Regulatory Affairs Specialist

Placements24; Willows (CA); Hybrid; USD 46,000 - 70,000; Full time

Benefits offered by this job

Medical aid

Pension fund

Hybrid role in Welkom

Job summary

Placements24 in Welkom is seeking an experienced Pharmaceutical Regulatory Affairs Specialist to ensure compliance with national and international regulations. You will prepare and submit regulatory dossiers, liaise with health authorities, and monitor evolving guidelines to keep products on track for approval.

The role demands a strong grasp of SAHPRA processes, ICH guidelines, and meticulous documentation, with collaboration across R&D, QA, and marketing.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or related field.
• Master’s degree or regulatory qualification advantageous.
• Minimum 4 years regulatory affairs experience with SA regulatory landscape.
• Experience preparing regulatory dossiers and submissions.
• Knowledge of ICH guidelines and submission requirements.
• Excellent attention to detail and organizational skills.
• Strong communication and stakeholder management.
• Proficiency with regulatory information systems and office software.

Responsibilities

• Prepare, review, and submit regulatory filings, including marketing authorization applications, variations, and renewals, to SAHPRA and other authorities.
• Ensure all regulatory documentation is accurate, complete, and compliant with current guidelines.
• Liaise directly with regulatory agencies to address queries and facilitate approvals.
• Monitor regulatory changes and assess impact on products and strategies.
• Develop and maintain regulatory strategies for new product development and lifecycle management.
• Collaborate with cross-functional teams to provide regulatory guidance and support.
• Maintain regulatory submission databases and track approvals.

Skills

Regulatory knowledge

Dossier submission

Regulatory strategy

Cross-functional collaboration

Education

Bachelor's degree in Pharmacy or related field

Tools

Regulatory Information Management System (RIMS)

Job description

Placements24 in Welkom is seeking an experienced Pharmaceutical Regulatory Affairs Specialist to ensure compliance with national and international regulations. You will prepare and submit regulatory dossiers, liaise with health authorities, and monitor evolving guidelines to keep products on track for approval.

The role demands a strong grasp of SAHPRA processes, ICH guidelines, and meticulous documentation, with collaboration across R&D, QA, and marketing.