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Biophore
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Regulatory Affairs - API & Formulations

Regulatory Affairs - API & Formulations

Biophore

3 - 8 years

2 - 5 Lacs

Hyderabad

Posted:1 week ago| Platform:

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Skills Required

Formulation Research Development drug regulatory affairs Api Production Dmf US Market Regulatory Affairs Anda

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Work from Office

Job Type

Full Time

Job Description

Accountable to develop, implement and communicate the regulatory strategies to support registration activities for all Products for all global markets such as US, EU, Canada, Gulf and ROW Market. Lead, manage and develop leading edge regulatory strategies leading to successful regulatory filings and approvals for Generics for Global markets. implement changes required to comply with new regulatory requirements and to effectively lead and direct the creation of required data packages and facilitate knowledge for drug development. Collaborate with development and other cross functional teams during the product development activities to provide appropriate CMC as well as regulatory strategies. critical regulatory requirements to meet the quality submission and timely approvals. Responsible for all queries received from Agency or customers. Post-approval changes and Post approval compliance. communicate critical aspects of ongoing project activities and influence internal/external stakeholders to meet the regulatory requirements.

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Biophore

www.biophore.com

Biotechnology

Hyderabad

200+ Employees

90 Jobs

Key People

Dr. V. Raghavendra

Founder & CEO
Mr. Gupta H

Chief Financial Officer
Dr. Priya Sharma

Chief Scientific Officer

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