RA Pharmacist : Multinational generic PHARMACEUTICAL leader : Growing

Whizants; Johannesburg; On-site; ZAR 600,000 - 800,000; Full time

Job summary

A growing multinational pharmaceutical company in Johannesburg is seeking a Regulatory Affairs Specialist with at least 7 years of expertise in pharmaceutical regulations. The role involves ensuring compliance with guidelines, reviewing product labelling, and collaborating with quality assurance teams. A pharmacist degree registered with SAPC is essential. This position offers career development in a thriving environment.

Qualifications

• Minimum of 7 years pharmaceutical regulatory expertise.
• Registered with the SAPC.
• Experience in the compilation and submission of drug applications.

Responsibilities

• Monitor regulatory compliance and provide guidance on issues.
• Develop and review product labelling and packaging.
• Collaborate with quality assurance teams for compliance.
• Conduct post-marketing surveillance and pharmacovigilance.
• Analyze regulatory changes and advise accordingly.

Skills

PHARMACEUTICAL Regulatory expertise

Regulatory compliance monitoring

Labelling and packaging review

Post-marketing activities

Regulatory intelligence

Education

Pharmacist Degree

Job description

Overview

Midrand-corporate office of growing multinational.

an Employer of choice with the best leadership and employee wellbeing " Growth is phenomenal offering the individual career-pathing and development

Qualifications

Must have minimum requirements :

• PHARMACEUTICAL Regulatory expertise of minimum 7 years is essential for the role (Knowledge of generic registrations)
• Pharmacist Degree - registered with SAPC.
• Medicine registration and CTD / eCTD training
• Regulatory experience and skill in the compilation, preparation, submission and maintenance of dossiers and new drug applications.

Advantageous : Quality expertise of one year plus.

Key responsibilities and accountabilities

• Regulatory Compliance: Monitor and ensure compliance with regulatory guidelines and requirements. Stay updated with changes in regulations and assess the impact on the organization\'s products and processes and also provide guidance to internal stakeholders on compliance matters.
• Labelling and Packaging: Involved in the development and review of product labelling and packaging materials to ensure compliance with regulatory requirements. Ensure that the information provided is accurate, clear, and in line with regulatory guidelines.
• Quality Assurance Support: Collaborate with quality assurance teams to ensure that manufacturing processes and facilities comply with regulatory standards.
• Post-Marketing Activities: Involved in post-marketing surveillance and pharmacovigilance activities. Monitor and report adverse events, evaluate safety data, and ensure that appropriate actions are taken to protect patient safety.
• Regulatory Intelligence: Stay updated with the latest regulatory developments, guidelines, and best practices. Be able to analyze the impact of regulatory changes on the organization and provide recommendations for compliance.

Timeframe : to interview and offer to the successful candidate asap.