Senior Regulatory Affairs Specialist Global Dossier Expert

Placements24; Mtubatuba Local Municipality; Presencial; ZAR 1.100.000 - 1.700.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health benefits

Travel opportunities

Career development

Descripción de la vacante

Placements24 is seeking a Senior Regulatory Affairs Specialist for its Richards Bay, KwaZulu-Natal operations. You will lead regulatory strategies, prepare and submit CTD/eCTD dossiers, and liaise with global health authorities to ensure timely market approvals and ongoing compliance.

Collaboration with R&D, QA, and commercial teams is essential to align regulatory plans with business goals. The role requires 6+ years in regulatory affairs, strong communication, and meticulous attention to

Formación

• Bachelor's degree in Pharmacy, Life Sciences or related field; advanced degree preferred.
• Minimum of 6 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of pharmaceutical regulations (FDA, EMA, SAHPRA) and guidelines.
• Experience preparing and submitting regulatory dossiers for multiple regions.
• Excellent written and verbal communication, detail-oriented.

Responsabilidades

• Develop and implement regulatory strategies for product registration and lifecycle management.
• Prepare, review, and submit regulatory dossiers (CTD/eCTD) to health authorities globally.
• Liaise with regulatory agencies to address queries and facilitate approvals.
• Monitor evolving regulatory guidelines and advise on compliance strategies.
• Manage post-approval changes and ongoing regulatory compliance.
• Provide regulatory input to product development teams.
• Conduct regulatory assessments for new product opportunities and market entries.
• Maintain regulatory databases and documentation systems.
• Collaborate with cross-functional teams to ensure compliance across operations.

Conocimientos

Regulatory strategy

Regulatory communications

Document management

Cross-functional collaboration

Regulatory submissions

SAHPRA knowledge

Educación

Bachelor's degree in Pharmacy/Life Sciences

Advanced degree preferred

Herramientas

Regulatory information systems

CTD/eCTD familiarity

Descripción del empleo

Placements24 is seeking a Senior Regulatory Affairs Specialist for its Richards Bay, KwaZulu-Natal operations. You will lead regulatory strategies, prepare and submit CTD/eCTD dossiers, and liaise with global health authorities to ensure timely market approvals and ongoing compliance.

Collaboration with R&D, QA, and commercial teams is essential to align regulatory plans with business goals. The role requires 6+ years in regulatory affairs, strong communication, and meticulous attention to