Hyderabad
INR 7.0 - 11.0 Lacs P.A.
Work from Office
Full Time
1.Author, review, prepare dossier for US and EU markets (ANDA/505(b)2 applications/ MAA), regulatory and non regulatory market. 2.Regulatory strategy design, preparation, gap analysis of submission documents and authoring technical reports for cross functional teams. 3.Pre and Post approval submission management activities for approved products. 4.Minimum 5 ? 8 years experience in regulatory and non regulatory market with Master?s degree.
Hyderabad
INR 11.0 - 15.0 Lacs P.A.
Work from Office
Full Time
Prepare and submit regulatory dossiers for product registrations, import licenses, and amendments to the CDSCO. Maintain up-to-date knowledge of Indian medical device regulations (Medical Device Rules, 2017 and amendments). Liaise with CDSCO, state licensing authorities, and third-party regulatory consultants. Support Quality Assurance in audits, product recalls, and field safety corrective actions. Ensure compliance with India-specific labeling, documentation, and advertising regulations. Monitor and assess changes in regulatory guidelines and communicate impact to cross-functional teams. Maintain regulatory files and tracking systems for timely renewals and updates. Collaborate with global regulatory teams to ensure consistent strategies and compliance. Requirement: Master s degree in Pharmacy or a related field 5 8 years of hands-on experience in regulatory affairs for medical devices and experience with Class C & D devices preferred Strong knowledge of CDSCO regulations and submission pathways Excellent communication and project management skills Familiarity with ISO 13485, EU MDR, and US FDA regulations is a plus
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