Regulatory Associate- Biosimilar combination product

As a Regulatory Affairs Professional specializing in biosimilar combination products at Dr. Reddys Laboratories Ltd., your role involves developing and executing global regulatory strategies for combination product devices. Your responsibilities include ensuring compliance with evolving regulatory requirements from agencies such as the FDA, EMA, MHRA, and other global health authorities. You will provide regulatory guidance on device design, human factors, risk management, and manufacturing considerations. Additionally, you will lead and coordinate regulatory submissions for biosimilar combination products, including IND, BLA, and EU MDR filings. It is crucial to ensure accurate regulatory documentation for design control, risk assessment, usability studies, and post-market surveillance. Collaboration with R&D, Quality, Clinical, and Manufacturing teams is essential to align regulatory strategies with product development. Furthermore, you will support design verification and validation activities, including human factors engineering (HFE) and risk management. Your role also involves providing regulatory support for product lifecycle management, including manufacturing changes, labeling updates, and device modifications. Qualifications required for this position include: - 5+ years of regulatory affairs experience in biosimilars, biologics, or combination product development. As a Regulatory Affairs Professional specializing in biosimilar combination products at Dr. Reddys Laboratories Ltd., your role involves developing and executing global regulatory strategies for combination product devices. Your responsibilities include ensuring compliance with evolving regulatory requirements from agencies such as the FDA, EMA, MHRA, and other global health authorities. You will provide regulatory guidance on device design, human factors, risk management, and manufacturing considerations. Additionally, you will lead and coordinate regulatory submissions for biosimilar combination products, including IND, BLA, and EU MDR filings. It is crucial to ensure accurate regulatory documentation for design control, risk assessment, usability studies, and post-market surveillance. Collaboration with R&D, Quality, Clinical, and Manufacturing teams is essential to align regulatory strategies with product development. Furthermore, you will support design verification and validation activities, including human factors engineering (HFE) and risk management. Your role also involves providing regulatory support for product lifecycle management, including manufacturing changes, labeling updates, and device modifications. Qualifications required for this position include: - 5+ years of regulatory affairs experience in biosimilars, biologics, or combination product development.