Remote Regulatory Affairs Specialist — Global Submissions

Placements24; Paarl; Hybrid; ZAR 800,000 - 1,100,000; Full time

Benefits offered by this job

Health insurance

Retirement contributions

Performance bonuses

Job summary

Placements24 in South Africa is seeking a highly motivated Remote Pharmaceutical Regulatory Affairs Specialist. You will manage regulatory submissions, ensure compliance with global requirements, and contribute to strategic planning for a diverse product portfolio from a home office.

The ideal candidate has a strong regulatory background, CTD experience, and excellent communication skills. This fully remote role supports collaboration with cross-functional teams and regulatory authorities across

Qualifications

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or related field.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs.
• Experience with CTD and electronic submissions.
• Familiarity with SAHPRA, FDA and EMA requirements.

Responsibilities

• Prepare, review, and submit regulatory documentation for new drug applications, variations and renewals.
• Ensure submissions comply with regulations in target markets (SAHPRA, FDA, EMA).
• Liaise with regulatory authorities and respond to queries promptly.
• Maintain regulatory databases and timely updates of registrations.
• Collaborate with R&D, Quality, Marketing to gather information for submissions.
• Monitor regulatory changes and assess impact on products.
• Provide regulatory guidance to project teams throughout the lifecycle.
• Review promotional materials for regulatory compliance.
• Develop and implement regulatory strategies for product approvals.
• Manage regulatory timelines and milestones remotely.

Skills

Regulatory submissions

CTD preparation

Remote work

Regulatory strategy

Communication skills

Regulatory information management

Education

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

Tools

RIM systems

Electronic submissions software

Job description

Placements24 in South Africa is seeking a highly motivated Remote Pharmaceutical Regulatory Affairs Specialist. You will manage regulatory submissions, ensure compliance with global requirements, and contribute to strategic planning for a diverse product portfolio from a home office.

The ideal candidate has a strong regulatory background, CTD experience, and excellent communication skills. This fully remote role supports collaboration with cross-functional teams and regulatory authorities across