Senior Regulatory Pharmacist: Dossier & Compliance Expert

Agility Hr Solutions Pty; Gauteng; On-site; ZAR 300 000 - 400 000; Full time

Job summary

A global pharmaceutical company is seeking a Senior Regulatory Affairs Pharmacist. The ideal candidate will have at least 8 years of experience and a pharmacist degree. Responsibilities include ensuring regulatory compliance, participating in labelling development, and engaging in post-marketing activities. Proficiency in South African languages and excellent communication skills are required. This is a full-time position with negotiable remuneration.

Qualifications

• Minimum 8 years of experience as a Regulatory Pharmacist.
• Exposure to Quality Assurance advantageous.
• Currently working at a generic pharmaceutical company specializing in orthodox medicines.
• Training in medicine registration and CTD/eCTD processes required.
• Experience in regulatory dossier compilation and submission.
• Proficiency in at least one South African language.
• Excellent written and verbal communication skills.
• Ability to manage multiple tasks with attention to detail.
• Flexible attitude towards work assignments.

Responsibilities

• Monitor compliance with regulatory guidelines.
• Participate in the development and review of product labelling.
• Collaborate with quality assurance teams for regulatory standards.
• Engage in post-marketing surveillance and pharmacovigilance.
• Analyze impact of regulatory changes and provide recommendations.

Skills

Proofreading

Adobe Acrobat

FDA Regulations

Manufacturing & Controls

Biotechnology

Clinical Trials

Research & Development

GLP

cGMP

Product Development

Chemistry

Writing Skills

Education

Pharmacist degree & registration with SAPC

Tools

DocuBridge

Job description

A global pharmaceutical company is seeking a Senior Regulatory Affairs Pharmacist. The ideal candidate will have at least 8 years of experience and a pharmacist degree. Responsibilities include ensuring regulatory compliance, participating in labelling development, and engaging in post-marketing activities. Proficiency in South African languages and excellent communication skills are required. This is a full-time position with negotiable remuneration.