SUMMARY:
Role due to growth for an experienced Regulatory Affairs Pharmacist with generic industry background: SA-Midrand
POSITION INFO:
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
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.
