11 Sugam Jobs

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...

Company Name: Exemed Pharmaceuticals Designation - Drug Regulatory Affairs -Officer/Sr Officer Location - Vadodara ( Corporate Office) Market: Domestic Primary Job Descriptions Having knowledge of SUGAM portal and CDSCO website Submission for Mfg. & Mkt. Applications [CT21/CT-18] for IND, New Drug, Subsequent New Drug, FDC. Application of CT-05 / CT- 04 Application of CT-10 / 12/ 13 Application of import Licenses [CT-16/ Form 12/Form 08] Knowledge of IPC submissions Form 29 application Preparation of presentation for Subject Expert committee (SEC) Product Lifecycle & Management Additionally, should be well verse with Preparation of Module 4 & 5 Nonclinical & Clinical data Preparation of Pack...

Regulatory Affairs Job Opportunity! Desired Experience : 3- 9 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Designation: Senior Executive/ Executive Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy Job Responsibilities: Responsible for Regulatory submission to Indian NRA, Emerging Markets, Regulated Markets and World Health Organization. Experienced in handling, management and expansion of product portfolios, markets/ territories. Experienced in the preparation, review and submission of applications/ response to RCGM vide IBSC. Expertise in preparation, compilation and submission of Indian NRA applications (Eg: Form CT 10, 16, CT18, 40, 10, E...

ensure timely submission, follow-up, and compliance with Food and Drug Administration (FDA) requirements for licenses, approvals, renewals, and regulatory documentation, in coordination with internal departments and relevant authorities.

Company Name: Exemed Pharmaceuticals Designation - Drug Regulatory Affairs -Officer/Sr Officer Location - Vadodara ( Corporate Office) Market: Domestic Primary Job Descriptions Having knowledge of SUGAM portal and CDSCO website Submission for Mfg. & Mkt. Applications [CT21/CT-18] for IND, New Drug, Subsequent New Drug, FDC. Application of CT-05 / CT- 04 Application of CT-10 / 12/ 13 Application of import Licenses [CT-16/ Form 12/Form 08] Knowledge of IPC submissions Form 29 application Preparation of presentation for Subject Expert committee (SEC) Product Lifecycle & Management Additionally, should be well verse with Preparation of Module 4 & 5 Nonclinical & Clinical data Preparation of Pack...

Key responsibilities Prepare and submit applications via the SUGAM portal (Form 41 & 46) to relevant authorities (DCGI, IVRI, Krishibhavan, and DAHD) for veterinary products. Compile, review, and prepare CTD/eCTD dossiers for veterinary vaccines and APIs in compliance with CDSCO and international guidelines. Handle end-to-end veterinary product registration, including new applications, renewals, updates, and query responses. Track application status, follow up with authorities, and ensure timely responses to regulatory queries and deficiencies. Support audits by CDSCO and other bodies; maintain organized, inspection-ready documentation and records. Review and approve product Labelling and pa...

Regulatory Affairs Job Opportunity! Desired Experience : 3- 15 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Designation: Senior Manager/ Manager/ Deputy Manager/ Assistant Manager/ Senior Executive/ Executive Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy Job Responsibilities: Responsible for Regulatory submission to Indian NRA, Emerging Markets, Regulated Markets and World Health Organization. Experienced in handling, management and expansion of product portfolios, markets/ territories. Experienced in the preparation, review and submission of applications/ response to RCGM vide IBSC. Expertise in preparation, compilation and submission of...

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...

Desired Experience : 3-7 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Designation: Deputy Manager/ Assistant Manager/ Senior Executive/ Executive Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy Main purpose of the Job: Responsible for Preparation of Regulatory Documents for submission to Indian NRA, WHO and other Regulatory Authorities. Job Responsibilities: 1. Preparation of following Regulatory Submission Packages related to NRA submissions but not limited to. a. Application for Post Approval Change(s) b. Marketing Authorization Applications c. Clinical trial applications d. Support the submission of Import licenses/ export NoC e. Support...

Job Description: 1 . Hands on Experience in regulatory submissions preferably for Blood products and Biologics. 2. Review/Submission of applications for new products Manufacturing licenses and renewals. 3. Experience on procedures for application of new drugs (NOC's and Test licenses). 4. Monitoring and ensuring allp certificates (COPPs, GMP, GLP, WHO-GMP and FSC Production Capacity and Performance Certificate) renewals and approvals up to date. 5. Review of Tender certificate. 6. Co-ordinate with Drug control authority personnel for License approvals. 7. Review of Dossiers. 8. Submission of Samples and Documents to NIB, Noida for testing. 9. Updation of the National and international legisl...

Key responsibilities Must have experience with the SUGAM portal and CDSCO online submission process. Prepare and submit applications via the SUGAM portal (Form 41 & 46) to relevant authorities (DCGI, IVRI, Krishibhavan, and DAHD) for veterinary products. Compile, review, and prepare CTD/eCTD dossiers for veterinary vaccines and APIs in compliance with CDSCO and international guidelines. Handle end-to-end veterinary product registration, including new applications, renewals, updates, and query responses. Track application status, follow up with authorities, and ensure timely responses to regulatory queries and deficiencies. Support audits by CDSCO and other bodies; maintain organized, inspect...