Regulatory Associate Dr. Reddy's Laboratories

5.0 - 9.0 years

0 Lacs

hyderabad, telangana

On-site

As a highly skilled Regulatory Affairs Professional specializing in biosimilar combination products (drug-device combinations), your main responsibility will be to develop and execute global regulatory strategies for combination product devices. You will play a crucial role in ensuring compliance with evolving regulatory requirements from agencies such as the FDA, EMA, MHRA, and other global health authorities. To excel in this role, you should have a minimum of 5 years of regulatory affairs experience in biosimilars, biologics, or combination product development. Your expertise will be instrumental in providing regulatory guidance on device design, human factors, risk management, and manufacturing considerations. You will lead and coordinate regulatory submissions for biosimilar combination products, including IND, BLA, and EU MDR filings. Accuracy in regulatory documentation for design control, risk assessment, usability studies, and post-market surveillance will be critical in this position. Collaboration with R&D, Quality, Clinical, and Manufacturing teams is essential to align regulatory strategies with product development. You will also support design verification and validation activities, including human factors engineering (HFE) and risk management. Your role will involve providing regulatory support for product lifecycle management, including manufacturing changes, labeling updates, and device modifications. By leveraging your expertise in regulatory affairs, you will contribute significantly to the success of regulatory processes for biosimilar combination products.,

Posted 1 week ago

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