Remote Senior Regulatory Submissions Specialist – Global

Placements24; Gqeberha; Hybrid; ZAR 900,000 - 1,400,000; Full time

Benefits offered by this job

Competitive salary

Medical aid

Pension

Bonuses

Career advancement

Job summary

Placements24 is seeking a Senior Regulatory Affairs Specialist for a dynamic pharmaceutical company. This role offers remote work from Port Elizabeth, Eastern Cape, while contributing to global regulatory strategy and submitting dossiers to health authorities worldwide.

You will prepare CTD/eCTD submissions, liaise with SAHPRA, FDA, and EMA, ensure compliance, guide R&D and clinical teams, and stay abreast of evolving guidelines.

Qualifications

• 5+ years of progressive pharmaceutical regulatory experience.
• Experience preparing and submitting regulatory dossiers to major health authorities.
• Strong knowledge of ICH, FDA, EMA, SAHPRA guidelines.
• Excellent written and verbal communication with technical writing skills.
• Ability to manage multiple projects in a remote, fast-paced environment.

Responsibilities

• Prepare regulatory dossiers (CTD/eCTD) for NDAs, MAAs, and variations.
• Liaise with health authorities (SAHPRA, FDA, EMA) to facilitate reviews.
• Ensure submissions comply with current guidelines and standards.
• Develop regulatory strategies for registration and lifecycle management.
• Review labeling and promotional materials for compliance.
• Provide regulatory guidance to R&D, clinical, and commercial teams.
• Stay updated on evolving regulatory requirements and best practices.
• Maintain regulatory databases and track submission status.

Skills

Regulatory affairs

Regulatory submissions

Project management

Regulatory strategy

Education

Bachelor's degree in Pharmacy

Master's degree in related field

Job description

Placements24 is seeking a Senior Regulatory Affairs Specialist for a dynamic pharmaceutical company. This role offers remote work from Port Elizabeth, Eastern Cape, while contributing to global regulatory strategy and submitting dossiers to health authorities worldwide.

You will prepare CTD/eCTD submissions, liaise with SAHPRA, FDA, and EMA, ensure compliance, guide R&D and clinical teams, and stay abreast of evolving guidelines.