Remote Senior Regulatory Affairs Lead — Global Pharma

Placements24; Klerksdorp; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Remote-first work environment

Home office stipend

Professional development support

Flexible working hours

Job summary

Placements24 is seeking a Senior Pharmaceutical Regulatory Affairs Specialist to join a remote-based team. You will manage regulatory submissions, interact with health authorities, and provide strategic regulatory guidance across lifecycle stages from anywhere in South Africa.

The role requires extensive knowledge of FDA/EMA/ICH guidelines, 7+ years of experience, and the ability to work independently in a fast-paced, global environment.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology or related life science.
• Minimum 7 years' experience in pharmaceutical regulatory affairs.
• Experience with global regulatory requirements and submissions (FDA, EMA, ICH).
• Able to work remotely and manage multiple complex projects.

Responsibilities

• Prepare, review, and submit regulatory dossiers (CTD/IND/NDA) to health authorities worldwide.
• Interpret and apply global regulatory guidelines to product development and lifecycle management.
• Serve as primary point of contact for health authorities on assigned projects.
• Develop and implement regulatory strategies to support development, registration, and lifecycle maintenance.
• Provide regulatory guidance to cross-functional teams (R&D, clinical, manufacturing, marketing).
• Manage post-approval activities such as variations, renewals, and annual reports.
• Review promotional materials for regulatory compliance and participate in inspections/audits.

Skills

Regulatory strategy

Regulatory submissions

Health authority interactions

Regulatory intelligence

Remote project management

Education

Bachelor's degree in Pharmacy/related life science

Master's degree preferred

Job description

Placements24 is seeking a Senior Pharmaceutical Regulatory Affairs Specialist to join a remote-based team. You will manage regulatory submissions, interact with health authorities, and provide strategic regulatory guidance across lifecycle stages from anywhere in South Africa.

The role requires extensive knowledge of FDA/EMA/ICH guidelines, 7+ years of experience, and the ability to work independently in a fast-paced, global environment.