Regulatory Affairs Specialist - API Dr. Reddy's Laboratories

10.0 - 14.0 years

0 Lacs

hyderabad, telangana

On-site

As a Team Lead in Global Regulatory Affairs - API team at Dr. Reddys Laboratories Ltd., you play a crucial role in guiding and supporting your team in their operations. Your responsibilities include: - Defining regulatory requirements for the selection of Drug Master File starting materials and their suppliers - Guiding the teams in setting specifications for the starting materials, intermediates & Active Pharmaceutical Ingredient - Providing inputs for defining the control strategy for PGIs, nitrosamines & other regulatory expertise required - Ensuring smooth execution of regulatory filings globally according to the established plan - Monitoring and assessing the progress of Drug Master Fil...

Posted 22 hours ago

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Regulatory Executive Synnat Pharma

5.0 - 9.0 years

5 - 10 Lacs

Visakhapatnam

Work from Office

We are looking for a meticulous Executive/Sr. Executive to spearhead regulatory submissions and review at Synnat Pharma Private Limited. In this pivotal role, you will be instrumental in ensuring our API manufacturing processes adhere to global pharmaceutical regulations. Your expertise will be essential in compiling, reviewing, and submitting comprehensive regulatory documentation to various health authorities, including the US FDA, EMA, and CDSCO. You will manage regulatory inspections, handle queries, and lead the preparation of DMF filings. The ideal candidate will possess a deep understanding of regulatory guidelines, ICH guidelines, and relevant pharmacopeias (USP, EP, BP), coupled wit...

Posted 3 months ago

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