Regulatory Affairs Manager
1 week ago
We are seeking a highly skilled Regulatory Affairs Manager to join our team at SUN PHARMA in Vadodara, India.
Estimated Salary: ₹1200000 - ₹1800000 per annum
Job DescriptionThe successful candidate will be responsible for evaluating regulatory strategies for products to be registered in India. This will involve submission of applications on online portals for domestic manufacturing and marketing permission from DCGI, as well as import registration/import license of drugs and medical devices.
Evaluation of documents to be submitted with applications and coordination with respective teams for finalization is also a key aspect of the role.
The Regulatory Affairs Manager will also be responsible for evaluating and submitting applications for BE permission for export registration, permission to manufacture drugs for examination, test or analysis, and permission to import drugs for examination, test or analysis.
In addition, the successful candidate will need to review draft gazette notifications related to the regulatory domain and share comments on the same.
Reviewing market complaints raised by regulatory authorities and responding to queries raised by ASCI regarding consumer healthcare products are also important responsibilities of this role.
A Bachelor's degree in Pharmacy (M. Pharm) and 8-10 years of experience in Regulatory Affairs for the Indian market are required for this position.
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