Remote Senior Regulatory Affairs - Global Submissions

Placements24; Gqeberha; Hybrid; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Medical aid

Performance-based bonus

Remote work

Job summary

Placements24 is seeking a Senior Pharmaceutical Regulatory Affairs Specialist to join a dynamic, remote-enabled team. You will lead global submissions (NDAs, MAAs, ANDAs), prepare and review CTD modules, and liaise with authorities (SAHPRA, FDA, EMA) to obtain approvals while ensuring compliance.

The role requires 5+ years in regulatory affairs, a degree in Pharmacy or Life Sciences, and strong knowledge of eCTD and RIM systems.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or related field.
• Minimum 5 years in pharmaceutical regulatory affairs with global submissions.
• Proven experience preparing NDAs, MAAs, and ANDAs.
• Strong knowledge of SAHPRA, FDA, and EMA submission requirements.
• Experience with eCTD publishing and regulatory information management systems.

Responsibilities

• Develop and implement regulatory strategies for NDAs/MAAs/other submissions.
• Prepare, review, and manage CTD modules and submission dossiers.
• Liaise with health authorities on requirements, deficiencies, and approvals.
• Monitor global guidelines and advise impact on products and strategies.
• Manage post-approval activities including variations and lifecycle management.
• Collaborate with R&D, QA, and Commercial to gather data for submissions.
• Maintain regulatory databases and tracking systems.
• Provide regulatory guidance to internal stakeholders and participate in inspections.

Skills

Regulatory strategy

Global submissions

eCTD publishing

Cross-functional collaboration

Independent work

Education

Bachelor's or Master's degree in Pharmacy/Life Sciences/Chemistry

Tools

eCTD publishing software

RIM systems

Job description

Placements24 is seeking a Senior Pharmaceutical Regulatory Affairs Specialist to join a dynamic, remote-enabled team. You will lead global submissions (NDAs, MAAs, ANDAs), prepare and review CTD modules, and liaise with authorities (SAHPRA, FDA, EMA) to obtain approvals while ensuring compliance.

The role requires 5+ years in regulatory affairs, a degree in Pharmacy or Life Sciences, and strong knowledge of eCTD and RIM systems.