Remote Senior Regulatory Affairs Leader - Global Approvals

Placements24; United States; Remote; USD 120,000 - 170,000; Full time

Benefits offered by this job

Remote work flexibility

Professional development

Job summary

Placements24 seeks a Senior Regulatory Affairs Specialist for a fully remote position. You will lead global regulatory strategies, manage NDAs/variations, and coordinate CTD/eCTD submissions across US, EU, and other markets.

Ideal candidates bring 5+ years in pharma regulatory affairs, strong communication, and ability to drive multiple complex projects in a remote setting. The role offers flexible location and international collaboration opportunities.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology or related life science.
• Advanced degree (MSc, PhD) or regulatory affairs certification is advantageous.
• Minimum 5 years of pharmaceutical regulatory affairs experience.
• Experience with CTD/eCTD submissions and major markets (US, EU, SA).
• Excellent written and verbal communication; detail-oriented.

Responsibilities

• Develop and execute global regulatory strategies for NDAs, variations, and renewals.
• Prepare, review, and submit regulatory dossiers (CTD/eCTD) to health authorities.
• Liaise with regulatory agencies (FDA, EMA, SAHPRA) to facilitate reviews.
• Ensure regulatory compliance across submissions and post-approval changes.
• Mentor junior regulatory professionals and support cross-functional teams.
• Maintain regulatory databases and monitor evolving requirements.

Skills

Regulatory strategy

Project management

Regulatory submissions

Written & verbal communication

Attention to detail

Analytical thinking

Remote collaboration

Independence

Education

Bachelor's degree in Pharmacy, Chemistry, Biology or related life science

Advanced degree / regulatory affairs certification

Tools

Regulatory information management systems

MS Office

Job description

Placements24 seeks a Senior Regulatory Affairs Specialist for a fully remote position. You will lead global regulatory strategies, manage NDAs/variations, and coordinate CTD/eCTD submissions across US, EU, and other markets.

Ideal candidates bring 5+ years in pharma regulatory affairs, strong communication, and ability to drive multiple complex projects in a remote setting. The role offers flexible location and international collaboration opportunities.