Posted:6 days ago|
Platform:
Work from Office
Full Time
Key Responsibilities: Lead and manage regulatory activities and documentation (individually and through a team). Ensure compliance with South Africa/country-specific guidelines. Review and peer-review regulatory submissions (electronic & non-electronic). Track and oversee project timelines and regulatory deliverables. Liaise with internal/external stakeholders to ensure timely documentation. Prepare/review APQR summary reports and implementation notifications. Stay updated on changing regulatory legislation. Guide and train internal teams on regulatory requirements. Ideal Candidate Profile: 6-9 years of experience in Regulatory Affairs. Strong knowledge of South African and/or international regulatory guidelines. Background in Pharmacy, Life Sciences, or related field. Excellent documentation, analytical, and communication skills. Experience in handling submissions and quality checks under tight deadlines.
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