Remote Global Regulatory Affairs Specialist

Placements24; United States; Remote; USD 120,000 - 150,000; Full time

Benefits offered by this job

Remote work setup support

Flexible working hours

International exposure

Job summary

Placements24 is seeking a Remote Pharmaceutical Regulatory Affairs Specialist to enhance global compliance from anywhere. You will lead regulatory submissions, interpret evolving guidelines, and collaborate with cross-functional teams to ensure product lifecycle compliance across international markets.

The role emphasizes independent work, strategic regulatory submission planning, and strong communication to support global health outcomes in a fast-paced, innovation-driven environment.

Qualifications

• Minimum 5 years of progressive experience in pharmaceutical regulatory affairs.
• Proven track record preparing and submitting regulatory applications to SAHPRA, FDA, EMA.
• In-depth knowledge of ICH guidelines, GMP, GCP, and relevant pharmaceutical regulations.
• Excellent written and verbal communication skills for clear regulatory guidance.
• Proficiency with regulatory information management systems and electronic submission tools.

Responsibilities

• Prepare, review, and submit regulatory dossiers (CTD format) for new drug applications, variations, and renewals to global health authorities.
• Monitor evolving regulatory landscapes and provide strategic insights.
• Coordinate with R&D, Manufacturing, and Marketing to ensure timely regulatory submissions.
• Manage post-approval regulatory commitments, including variations and safety updates.
• Provide regulatory guidance to project teams throughout development.
• Maintain regulatory databases and documentation for accessibility and compliance.

Skills

5+ years experience

Regulatory submissions

ICH GMP GCP knowledge

Regulatory information management

Electronic submission tools

Education

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

Tools

Regulatory information management systems

Electronic submission tools

Job description

Placements24 is seeking a Remote Pharmaceutical Regulatory Affairs Specialist to enhance global compliance from anywhere. You will lead regulatory submissions, interpret evolving guidelines, and collaborate with cross-functional teams to ensure product lifecycle compliance across international markets.

The role emphasizes independent work, strategic regulatory submission planning, and strong communication to support global health outcomes in a fast-paced, innovation-driven environment.