Remote Regulatory Affairs Specialist – SA Dossier Expert

Placements24; Willows (CA); À distance; USD 110 000 - 150 000; Plein temps

Avantages offerts par ce poste

Remote salary package

Performance bonuses

Medical & life insurance

Professional development opportunities

Flexible working hours

Résumé du poste

Placements24 is seeking an experienced Regulatory Affairs Specialist to manage regulatory compliance for pharmaceutical products in the Free State region. You will prepare and submit dossiers, liaise with authorities, and ensure ongoing compliance across development, manufacturing, and marketing.

The role emphasizes remote work with focus on timely approvals, market access, and staying abreast of regulatory changes global and local. Collaboration with R&D and manufacturing is essential.

Qualifications

• Bachelor's degree in a scientific field required.
• Minimum 4 years of Regulatory Affairs experience in pharma.
• Familiarity with SAHPRA or equivalent regulatory systems.
• CTD dossier preparation experience preferred.

Responsabilités

• Prepare and submit regulatory dossiers for registrations, variations, and renewals.
• Liaise with regulators to secure approvals and address queries.
• Monitor regulatory changes and assess impact on products and processes.
• Ensure compliance with pharmaceutical regulations, guidelines, and internal policies.
• Provide regulatory support to R&D, manufacturing, and marketing teams.

Connaissances

Analytical skills

Regulatory affairs

Project management

Written & verbal communication

Formation

Bachelor's degree in Pharmacy

Bachelor's degree in Chemistry

Bachelor's degree in Life Sciences

Master's degree (advantage)

Description du poste

Placements24 is seeking an experienced Regulatory Affairs Specialist to manage regulatory compliance for pharmaceutical products in the Free State region. You will prepare and submit dossiers, liaise with authorities, and ensure ongoing compliance across development, manufacturing, and marketing.

The role emphasizes remote work with focus on timely approvals, market access, and staying abreast of regulatory changes global and local. Collaboration with R&D and manufacturing is essential.