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Regulatory Affairs Expert

2 months ago

Johannesburg, Gauteng, South Africa Curiska Full time

Regulatory Affairs Manager Position at Curiska

We are seeking a highly skilled Regulatory Affairs Manager to oversee product registration and dossier maintenance in the SEA Cluster, ensuring compliance with regulations and pharmacovigilance requirements.

Key Responsibilities

Regulatory Strategy: Develop and implement regulatory strategies and documentation.

Documentation: Ensure compliance with regulatory requirements, update dossiers, and develop Standard Operating Procedures (SOPs).

Safety Management: Handle safety updates, manage CMC/P&A variations, and oversee license renewals with authorities.

Audits: Manage internal and external audits.

Pharmacovigilance: Report and follow up on Adverse Drug Reactions (ADRs); provide local staff training.

Quality Management: Implement and maintain the Quality Management System, identify improvements, and provide training.

Environmental Compliance: Ensure adherence to environmental regulations.

Requirements

Education: Bachelor of Pharmacy (B. Pharm) and SAPC registration.

Experience: At least 10 years in Regulatory Affairs with human medicine and biologicals.

Skills: Proficient in product registration, pharmacovigilance, QA processes, and Microsoft Office Suite. Knowledge of ZAZIBONA and eCTD submissions is essential.

Personal Qualities: Detail-oriented, adaptable, organized, and a strong communicator.