Remote Regulatory Affairs Specialist — Global Dossier Leader

Placements24; Richards Bay; Ibrido; ZAR 900.000 - 1.300.000; Tempo pieno

Vantaggi offerti da questo lavoro

Fully remote

Flexible working hours

Health insurance

Professional development

Descrizione del lavoro

Placements24 is seeking a Pharmaceutical Regulatory Affairs Specialist to ensure products meet global regulatory requirements. This fully remote role is based in Richards Bay, KwaZulu-Natal, offering flexibility and autonomy.

You will prepare, submit, and maintain regulatory dossiers (CTD/MAA/ANDA) to authorities such as FDA, EMA and SAHPRA, manage submissions lifecycle, and provide regulatory guidance to R&D, quality and marketing.

Competenze

• 4–6 years of direct regulatory affairs experience.
• Experience preparing regulatory dossiers for major authorities (FDA, EMA, SAHPRA).
• Knowledge of ICH guidelines and submissions formats.
• Strong written and verbal communication skills.
• Ability to work independently in a remote setting.

Mansioni

• Prepare and submit regulatory dossiers (CTD, ANDA, MAA).
• Manage lifecycle of regulatory submissions (amendments, variations, renewals).
• Liaise with regulatory agencies and respond to queries during reviews.
• Ensure compliance with cGMP, GCP, and related regs.
• Review labeling, promotional materials, and technical docs for compliance.
• Conduct regulatory intelligence to stay updated on guidelines.
• Provide regulatory guidance to R&D, QA, and marketing.
• Assess regulatory implications of product changes and manufacturing changes.
• Maintain regulatory databases and records.

Conoscenze

Regulatory affairs

Regulatory dossiers

Regulatory submissions

Communication skills

Project management

Analytical skills

Formazione

Bachelor's degree in Pharmacy, Chemistry, Biology

Master's degree in Life sciences

Strumenti

Regulatory information systems

Descrizione del lavoro

Placements24 is seeking a Pharmaceutical Regulatory Affairs Specialist to ensure products meet global regulatory requirements. This fully remote role is based in Richards Bay, KwaZulu-Natal, offering flexibility and autonomy.

You will prepare, submit, and maintain regulatory dossiers (CTD/MAA/ANDA) to authorities such as FDA, EMA and SAHPRA, manage submissions lifecycle, and provide regulatory guidance to R&D, quality and marketing.