Global Regulatory Submissions Expert — On-site Queenstown

Placements24; Queenstown; On-site; NZD 120,000 - 160,000; Full time

Benefits offered by this job

Medical aid

Retirement fund contributions

Performance bonuses

On-site role in Queenstown

Job summary

Placements24 is seeking a Senior Regulatory Affairs Specialist for an on-site role in Queenstown. You will lead global regulatory submissions for NDAs, variations, and lifecycle activities, interpreting complex regulations and preparing high‑quality dossiers.

The position requires collaboration with R&D, manufacturing, and marketing to ensure compliant product development across markets. The ideal candidate has 5–7 years of regulatory affairs experience, deep knowledge of ICH/FDA/EMA/SAHPRA

Qualifications

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• 5–7 years of regulatory affairs experience in the pharmaceutical industry.
• Deep knowledge of global regulatory requirements (ICH, FDA, EMA, SAHPRA).
• Proven track record preparing and submitting regulatory dossiers.
• Strong project management and cross‑functional collaboration.

Responsibilities

• Develop regulatory strategies for global product development and lifecycle management.
• Prepare and review CTD/eCTD dossiers for NDAs, variations, and renewals.
• Liaise with authorities (FDA, EMA, SAHPRA) to address queries.
• Ensure compliance with local and international regulatory guidelines.
• Support post‑approval activities and labeling changes.

Skills

Regulatory strategy

Project management

Excellent communication

Education

Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or related field

Tools

Regulatory information management systems

Job description

Placements24 is seeking a Senior Regulatory Affairs Specialist for an on-site role in Queenstown. You will lead global regulatory submissions for NDAs, variations, and lifecycle activities, interpreting complex regulations and preparing high‑quality dossiers.

The position requires collaboration with R&D, manufacturing, and marketing to ensure compliant product development across markets. The ideal candidate has 5–7 years of regulatory affairs experience, deep knowledge of ICH/FDA/EMA/SAHPRA