6 Sugam Jobs

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 packaging to ensure regulatory compliance Review change control, assess PAC applicability, and prepare related submissions. Collaborate with R&D, QA, QC, Manufacturing, and Marketing to gather technical documents and provide regulatory inputs. Review technical documents and guide internal teams on regulatory standards, including new drug applications. Stay updated on evolving veterinary regulations and support the HOD in regulatory planning and decision-making. Skill Requirement Strong understanding of Indian regulatory frameworks including CDSCO. Must have experience with the SUGAM portal and CDSCO online submission process. In-depth knowledge of Form 41 and Form 46 requirements. Dossier preparation expertise for veterinary vaccines. Ability to interpret and apply regulatory guidelines accurately. Excellent communication, coordination, and project management skills. Job Location: Kadi,Gujarat (Bus transport facility available from Ahmedabad,Kalol & Kadi) Note: Immediate Joiner will be preferred first

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 Indian NRA applications (Eg: Form CT 10, 16, CT18, 40, 10, Export NoC, etc., but not limited) Well versed with Indian NRA submission portals, IBKP, SUGAM, NSWS, ODLS/ ONDLS, etc. Author, review and compilation of Regulatory Packages like Briefing documents, Scientific package, Pre-IND packages, Clinical Trial, Expedited request, Pre-qualifications, etc. Author, review, compile and submission of Marketing Authorization Applications (CTD/ ACTD/ eCTD) in India, Emerging Markets, Regulated Markets and Vaccine Prequalification Dossier to WHO. Application for Post Approval Change(s), Variations and Comparability packages Author, review and submission of responses to India, EM, WHO and Regulated markets.. Hands-on experience with MS office tools, PDF, Track Wise, DMS, Veeva Vault, Lorenz/ Pharma ready, etc.. Handling the Health Agency audits for India, EM, Regulated and WHO inspections Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution, Marketing and various teams (Internal & External). Review of Artworks (Labels and Package Insert) and Pack Profiles. Any other regulatory support required by the organization per submission need. Interested Candidates having relevant experience can send in their CVs to HR.Intern4@biologicale.com by mention the subject as Applying for "Regulatory Affairs"

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 language proficiency is a must Hands-on experience with: Gujarat FDA Portal Sugam NSWS CBN/NCB CDL Kasauli submissions

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 the preparation, review and submission of applications/ response to RCGM vide IBSC f. Support in handling of SUGAM, IBKP, NSWS & ONDLS/ ODLS sites 2. Assisting in Responding Queries to various regulatory authorities. 3. Preparation of dossiers / submission packages for NRA submissions. 4. Preparation of dossiers for registration in ROW countries. 5. Maintenance of Documentation Data base available with RA. 6. Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution and Marketing. 7. Routine Interaction with QA-documentation for updating Master Files. 8. Review of Pack Profiles. 9. Review of Artworks (Labels and Package Insert). 10. Preparation / compilation of technical documents related to tenders / queries. 11. Arranging Samples required for registration. 12. Any other support required by the other members of RA. Interested Candidates having relevant experience can send in their CVs to HR.Intern4@biologicale.com by mention the subject as Applying for Department Name

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 legislation, guidelines and customer practices. 10. Approval of Artworks. 11. Undertake and manage regulatory inspections. 12. Responsible to handle the SUGAM portals and Online Drug licencing system and National single window system (NSWS). 13. Complete knowledge on ROW and EU market registration. 14. Query response submission received from various M. 15. Coordination with the relevant departments for completion of Regulatory works.

Desired Experience : 3-7 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech 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 the preparation, review and submission of applications/ response to RCGM vide IBSC f. Support in handling of SUGAM, IBKP, NSWS & ONDLS/ ODLS sites 2. Assisting in Responding Queries to various regulatory authorities. 3. Preparation of dossiers / submission packages for NRA submissions. 4. Preparation of dossiers for registration in ROW countries. 5. Maintenance of Documentation Data base available with RA. 6. Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution and Marketing. 7. Routine Interaction with QA-documentation for updating Master Files. 8. Review of Pack Profiles. 9. Review of Artworks (Labels and Package Insert). 10. Preparation / compilation of technical documents related to tenders / queries. 11. Arranging Samples required for registration. 12. Any other support required by the other members of RA. Interested Candidates having relevant experience can send in their CVs to HR.Intern4@biologicale.com by mention the subject as Applying for Department Name