Regulatory Affairs Specialist
1 month ago
As a key member of our team, you will oversee product registration and dossier maintenance in the SEA Cluster, ensuring compliance with regulations and pharmacovigilance requirements. Key responsibilities include leading and managing regulatory strategies, ensuring compliance with regulatory requirements, and handling safety updates. Additionally, you will oversee license renewals with authorities, manage internal and external audits, and implement and maintain the Quality Management System. Requirements include a Bachelor of Pharmacy (B. Pharm) and SAPC registration, and at least 10 years of experience in Regulatory Affairs with human medicine and biologicals. Skills in product registration, pharmacovigilance, QA processes, and Microsoft Office Suite are essential. Personal qualities such as being detail-oriented, adaptable, organized, and a strong communicator are also required.
Key Responsibilities:
- Regulatory Strategy: Lead and manage regulatory strategies and documentation.
- Documentation: Ensure compliance with regulatory requirements, update dossiers, and develop 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 ADRs; provide local staff training.
- QMS: Implement and maintain the Quality Management System, identify improvements, and provide training.
- Environmental Compliance: Ensure adherence to environmental regulations.
- Additional Duties: Handle product recalls, manage complaints, and stay updated on laws and regulations.
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