Remote Senior Regulatory Affairs Specialist: Global Submissions

Placements24; Paarl; Remote; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Performance bonuses

Medical aid

Retirement provisions

Flexible remote work

Job summary

Placements24 is seeking a Senior Regulatory Affairs Specialist to join our team. This primarily remote role focuses on regulatory compliance for pharmaceutical products across international markets, with emphasis on Paarl, Western Cape.

You will prepare, submit, and maintain filings, liaise with health authorities, and guide internal teams on regulatory strategy. The ideal candidate has at least 6 years in pharmaceutical regulatory affairs, strong knowledge of FDA/EMA/SAHPRA guidelines, and

Qualifications

• 6+ years of progressive experience in pharmaceutical regulatory affairs.
• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or related field; Master's preferred.
• Deep knowledge of global regulatory submission requirements (FDA, EMA, SAHPRA).
• Experience preparing and managing regulatory submissions for various product types.
• Strong communication and project management skills; ability to meet tight deadlines.
• Eligible to work remotely in South Africa.

Responsibilities

• Prepare, review, and submit regulatory submissions to health authorities worldwide.
• Manage post-approval regulatory activities: amendments, renewals, variations.
• Interpret and apply global regulatory guidelines.
• Liaise with regulatory agencies; respond to queries and inspections.
• Provide regulatory guidance to cross-functional teams.
• Develop and maintain regulatory strategies for development and lifecycle management.
• Review promotional and labeling materials for regulatory compliance.
• Maintain regulatory documentation and databases.
• Stay abreast of changes in the regulatory environment and assess impact.

Skills

Regulatory submissions

Global regulatory guidelines

Cross-functional collaboration

Communication skills

Analytical thinking

Education

Bachelor's degree in Pharmacy, Chemistry, Life Sciences

Master's degree preferred

Tools

Regulatory information management systems

Job description

Placements24 is seeking a Senior Regulatory Affairs Specialist to join our team. This primarily remote role focuses on regulatory compliance for pharmaceutical products across international markets, with emphasis on Paarl, Western Cape.

You will prepare, submit, and maintain filings, liaise with health authorities, and guide internal teams on regulatory strategy. The ideal candidate has at least 6 years in pharmaceutical regulatory affairs, strong knowledge of FDA/EMA/SAHPRA guidelines, and