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8.0 - 12.0 years
0 Lacs
mumbai, maharashtra, india
On-site
Primary Job Function To lead and manage all regulatory affairs activities at the manufacturing site located at Mumbai and LL locations, ensuring timely regulatory submissions, compliance with regulations, and providing strategic support to institutional and international business operations. The role is critical to maintaining business continuity and regulatory compliance. Core Job Responsibilities Regulatory Submissions and compliance Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes e...
Posted 2 weeks ago
8.0 - 12.0 years
0 Lacs
mumbai, maharashtra, india
On-site
Primary Job Function To lead and manage all regulatory affairs activities at the manufacturing site located at Mumbai and LL locations, ensuring timely regulatory submissions, compliance with regulations, and providing strategic support to institutional and international business operations. The role is critical to maintaining business continuity and regulatory compliance. Core Job Responsibilities Regulatory Submissions and compliance Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes e...
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
gujarat
On-site
You will be responsible for coordinating with the plant and preparing online/offline applications through portals like Sugam, ONDLS, NSWS, and NDPS. Key Responsibilities: - Coordinate with the plant for commercial activities - Prepare online and offline applications through portals such as Sugam, ONDLS, NSWS, and NDPS Qualifications Required: - Previous experience as an Assistant Manager or in a similar managerial role - Strong management skills Please note that this job is based in the Corporate Office in Gujarat, IN and is offered by Dishman Carbogen Amcis Limited.,
Posted 1 month ago
8.0 - 12.0 years
0 Lacs
mumbai, maharashtra, india
On-site
JOB DESCRIPTION: Primary Job Function: To lead and manage all regulatory affairs activities at the manufacturing site located at Mumbai and LL locations, ensuring timely regulatory submissions, compliance with regulations, and providing strategic support to institutional and international business operations. The role is critical to maintaining business continuity and regulatory compliance. Core Job Responsibilities: Regulatory Submissions and compliance Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post...
Posted 2 months ago
15.0 - 24.0 years
9 - 19 Lacs
Ahmedabad
Work from Office
Role & responsibilities Key Responsibilities: Manage licenses: Manufacturing, Wholesale, FSSAI Coordinate with State FDAs (Gujarat, Jammu, Rajasthan) for: COPPs, FSCs, product permissions, and tender certificates Oversee submissions to Zonal CDSCO (Ahmedabad) Handle WHO GMP inclusion, GMP inspections, and CT-10/MA applications Liaise with CDL Kasauli/NIB for testing and analytical method transfers Manage NCB/CBN submissions (Import/Export licenses, returns) Respond to regulatory complaints and represent the company in court hearings Approve change controls, deviations, and product artworks Who We're Looking For: Strong working knowledge of Gujarat FDA, CDSCO (Zonal & Central) Gujarati langua...
Posted 5 months ago
 
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