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 3 weeks ago

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Specialist/ Sr. Specialist Regulatory Affairs Stryker

3.0 - 7.0 years

0 Lacs

haryana

On-site

As a Regulatory Affairs Specialist, you will play a crucial role in supporting the product lifecycle through obsolescence. Your responsibilities will include assessing changes made to the device post-launch to determine the regulatory impact of these changes on current clearance. You will ensure regulatory compliance by conducting thorough assessments and submitting the necessary documentation for product clearances and approvals from regulatory bodies such as the FDA and Notified Bodies. In this role, you will support new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based on regulatory changes. You wil...

Posted 3 months ago

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