Senior Regulatory Compliance Specialist

4 days ago


Agra, Uttar Pradesh, India beBeeRegulatoryAffairs Full time ₹ 60,00,000 - ₹ 1,30,00,000

Regulatory Affairs Manager - CMC Compliance

As a seasoned Regulatory Affairs professional, you will play a pivotal role in ensuring seamless compliance with regulatory requirements for our generic drug products. Your expertise in CMC regulatory activities, including ANDA submissions and review, will be instrumental in driving business success.

The ideal candidate will have a strong understanding of ICH, USFDA guidelines, and regulatory frameworks applicable to generic drug products. They will possess excellent technical document preparation and review skills, with experience in preparing and reviewing Module 2 & 3 documents (CTD format). Strong communication and interpersonal skills are also essential for successful collaboration with cross-functional teams.



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