Regulatory Affairs Professional

4 days ago


Jakarta, Jakarta, Indonesia Wellesta Full time
Job Description

We are seeking a highly skilled Regulatory Affairs Manager to join our team at Wellesta CPI. The successful candidate will be responsible for developing and implementing regulatory strategies for drug approvals and lifecycle management.

The ideal candidate will have a strong understanding of BPOM regulations and system implementation, as well as experience in preparing and submitting regulatory dossiers (IND, NDA, ANDA, MAA, CTA, etc.). They will also ensure compliance with FDA, EMA, MHRA, and other regulatory guidelines, and monitor regulatory changes to provide internal training on compliance updates.

The successful candidate will manage communications with health authorities and respond to regulatory queries, as well as proactively come up with solutions and issue management.



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