Regulatory Affairs Manager

21 hours ago


India Intas Pharmaceuticals Full time
Job Description:

We are seeking an experienced Regulatory Affairs Manager to join our team at Intas Pharmaceuticals. This role will be responsible for preparing and submitting applications and dossiers for registration of recombinant products, CGT products in India, and PCT applications.

The successful candidate will have a strong background in pharmaceutical regulations, excellent communication skills, and the ability to work independently. They will also be responsible for reviewing and submitting applications for MAA, PAC, CT, Form 11, Form CT-10, Form CT-16, and Dual Use NOC to obtain relevant DCGI approvals.

In addition, the Regulatory Affairs Manager will be responsible for updating and preparing the dossier and documents, as well as responding to queries raised by regulatory agencies. They will also impart training to subordinates on document preparation and guidance.

This is a challenging opportunity for someone who enjoys working in a fast-paced environment and has a keen eye for detail. If you are a motivated and organized individual with excellent communication skills, we encourage you to apply.



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