Senior Regulatory Affairs Specialist - Global Submissions

Placements24; Queenstown; Presencial; NZD 120.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical aid

Retirement fund contributions

Performance bonuses

On-site role in Queenstown

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory strategy

Project management

Excellent communication

Educación

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

Herramientas

Regulatory information management systems

Descripción del empleo

About the Role

Our client, a dynamic pharmaceutical company focused on innovative therapeutic solutions, is seeking a highly experienced Senior Regulatory Affairs Specialist to join their team in Queenstown, Eastern Cape . This crucial role will involve managing and executing global regulatory submissions for new drug applications (NDAs), variations, and lifecycle management activities. You will be responsible for interpreting regulatory requirements, preparing high-quality submission dossiers, and liaising with regulatory agencies worldwide. The ideal candidate will possess a strong understanding of global regulatory landscapes, excellent project management skills, and a proven track record of successful regulatory submissions. This is an on-site position in Queenstown , offering the opportunity to work within a dedicated and expert regulatory affairs department. Join a company committed to bringing essential medicines to patients worldwide.

Key Responsibilities

• Develop and execute regulatory strategies for product development and lifecycle management in key global markets.
• Prepare, review, and compile complex regulatory submission dossiers (e.g., CTD, eCTD) for new drug applications, variations, and renewals.
• Liaise directly with regulatory authorities (e.g., SAHPRA, FDA, EMA) to facilitate submission reviews and address queries.
• Ensure compliance with all applicable local and international regulatory requirements and guidelines.
• Manage post-approval regulatory activities, including annual reports, supplements, and labeling changes.
• Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, and marketing.
• Conduct regulatory intelligence activities to stay abreast of evolving regulations and ensure proactive compliance.
• Review promotional materials and labeling for regulatory compliance.
• Participate in regulatory audits and inspections.
• Contribute to the development and implementation of departmental SOPs and quality systems.

Requirements

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• Minimum of 5-7 years of experience in regulatory affairs within the pharmaceutical industry.
• In-depth knowledge of global regulatory requirements and submission processes (e.g., ICH, FDA, EMA, SAHPRA).
• Proven experience in preparing and submitting various types of regulatory dossiers.
• Excellent understanding of drug development processes and pharmaceutical manufacturing.
• Strong project management and organizational skills.
• Exceptional written and verbal communication and negotiation skills.
• Ability to work effectively independently and as part of a cross-functional team in Queenstown .
• Proficiency in regulatory information management systems and document management systems.
• Detail-oriented with a strong commitment to quality and compliance.

Benefits

• Our client offers a competitive salary and a comprehensive benefits package, including medical aid, retirement fund contributions, and performance bonuses.
• This on-site role in Queenstown provides excellent opportunities for career advancement within a growing pharmaceutical company.
• We invest in our employees' professional development through ongoing training, conference attendance, and opportunities for leadership growth.
• You will be part of a collaborative team working on exciting projects that have a real impact on global health.
• Our client is dedicated to fostering a supportive and innovative work environment in the Eastern Cape .