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Dr. Reddy's Laboratories
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Regulatory Associate- Biosimilar combination product

Regulatory Associate- Biosimilar combination product

Dr. Reddy's Laboratories

5 - 9 years

0 Lacs

hyderabad telangana

Posted:2 weeks ago| Platform: Shine logo

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Skills Required

regulatory affairs biosimilars biologics regulatory submissions design control risk assessment rd quality clinical manufacturing design verification validation human factors engineering product lifecycle management combination product development usability studies postmarket surveillance labeling updates

Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: You will be a highly skilled Regulatory Affairs Professional specializing in biosimilar combination products (drug-device combinations). Your primary responsibility will involve developing and executing global regulatory strategies for combination product devices. Your focus will be on ensuring compliance with evolving regulatory requirements from agencies such as the FDA, EMA, MHRA, and other global health authorities. Key Responsibilities: - Provide regulatory guidance on device design, human factors, risk management, and manufacturing considerations. - Lead and coordinate regulatory submissions for biosimilar combination products, including IND, BLA, and EU MDR filings. - Ensure accurate regulatory documentation for design control, risk assessment, usability studies, and post-market surveillance. - Work closely with R&D, Quality, Clinical, and Manufacturing teams to align regulatory strategies with product development. - Support design verification and validation activities, including human factors engineering (HFE) and risk management. - Provide regulatory support for product lifecycle management, including manufacturing changes, labeling updates, and device modifications. Qualifications Required: - 5+ years of regulatory affairs experience in biosimilars, biologics, or combination product development.,

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Regulatory Associate- Biosimilar combination product