Regulatory Affairs Specialist — CTD/eCTD Expert (Global)

Placements24; Paarl; Sur place; ZAR 700 000 - 1 000 000; Plein temps

Avantages offerts par ce poste

Medical aid

Life assurance

Provident fund

Annual leave

Résumé du poste

Placements24 seeks a Regulatory Affairs Specialist for its Paarl-based team. You will prepare, submit and maintain regulatory dossiers (CTD/eCTD) for new and existing medicines, ensuring SAHPRA, FDA and EMA compliance throughout the product lifecycle.

You will collaborate with R&D, Manufacturing and Quality Assurance, monitor regulatory changes, respond to agency queries, and guide cross-functional teams on regulatory strategies in the South Africa and international markets.

Qualifications

• Bachelor's degree in pharmacy, chemistry, biology or life sciences.
• 4–6 years in pharmaceutical regulatory affairs.
• Strong knowledge of CTD/eCTD and SAHPRA submission.
• Proficient in ICH, FDA, EMA guidelines.
• Excellent written and verbal communication.
• Ability to manage multiple dossiers and deadlines.

Responsabilités

• Prepare and compile regulatory submission dossiers (CTD, eCTD) for NDAs, variations and renewals.
• Ensure submissions meet requirements of SAHPRA, FDA and EMA.
• Liaise with R&D, Manufacturing and QA to gather information for submissions.
• Monitor regulatory changes and assess impact on products and strategies.
• Maintain regulatory documentation and databases with accuracy.
• Respond to health authority queries during reviews.
• Manage post-approval regulatory commitments and ongoing compliance.
• Review promotional materials and labeling for regulatory compliance.
• Provide regulatory guidance to cross-functional teams.
• Contribute to development and implementation of regulatory strategies.

Connaissances

Regulatory affairs

Documentation drafting

Attention to detail

Communication skills

Formation

Bachelors in Pharmacy/ Chemistry/ Biology

Outils

RIMS

CTD/eCTD

Description du poste

Placements24 seeks a Regulatory Affairs Specialist for its Paarl-based team. You will prepare, submit and maintain regulatory dossiers (CTD/eCTD) for new and existing medicines, ensuring SAHPRA, FDA and EMA compliance throughout the product lifecycle.

You will collaborate with R&D, Manufacturing and Quality Assurance, monitor regulatory changes, respond to agency queries, and guide cross-functional teams on regulatory strategies in the South Africa and international markets.