Executive- Regulatory Affairs

6 days ago


Delhi, Delhi, India Kusum Full time ₹ 8,00,000 - ₹ 24,00,000 per year

Role & responsibilities

Responsible for CDSCO, DCGI, state FDA work compliances

  1. Coordination with CDSCO to get clarity on few of our products whether they are under new drug or old drug.

  2. Preparation and online submission of BA/BE NOC application to CDSCO.

  3. Preparation and online submission of CT-10 for manufacturing the new drug (Indore & Bhiwadi).

  4. Preparation and online submission of CT-16 & Form 12 for import of new & old drug.

  5. Prepare application for COPP NOC for Indore site and Bhiwadi site.

  6. Response the queries to DCGI for the application (BE/BA NOC, Form CT-10, Form CT-16 & Form 12, COPP NOC.

  7. Preparation of application for renewal of certificate (WHO-GMP, manufacturing license, wholesale license, FSSAI, DSIR).

  8. COPP's for all countries, Product permission (domestic & export), FSC, Form 29, export NOC, Shelf life extension of products.

Preferred candidate profile

Understanding of FD&C Act and experience of Liaoning with CDSCO and State FDA.

Experience of applying Form 29, Form 12, CT-05, CT-10, CT-16 and other applications/licenses.



  • Delhi, Delhi, India Oswal Crop Protection Pvt. Ltd. Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Company DescriptionOswal Crop Protection Pvt. Ltd. is an ISO 9001:2015 certified company, established by Mr. Ramesh Bansal, who has over 30 years of experience in the pesticides industry. As one of the leading agrochemical companies in India, Oswal Crop Protection is committed to strengthening agriculture with sustainable products and services. Our marketing...


  • Delhi, Delhi, India Ace Cathtech Pvt. Ltd. Full time ₹ 6,00,000 - ₹ 9,00,000 per year

    Company DescriptionAce Cathtech Pvt Ltd, established in April 2024, is a cutting-edge manufacturer of premium medical devices, specializing in Nephrology Products, Cardiac Surgery Equipment, Critical Care, and Anesthesia Products. Located in Faridabad, Haryana, our state-of-the-art facility adheres to the highest manufacturing standards, including a Class 7...


  • Delhi, Delhi, India Intrinseque Health Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    The Regulatory Affairs Associate will manage the preparation, review, and submission of regulatory documents to ensure compliance with applicable regulations. The role will involve monitoring adherence to regulatory requirements, staying updated on relevant guidelines, and providing strategic input on regulatory matters.QualificationsKnowledge of Regulatory...


  • Delhi, Delhi, India Edusoft Healthcare Limited Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Company DescriptionEdusoft Healthcare Limited is at the forefront of healthcare innovation, delivering top-notch radiology equipment for better diagnostics and patient outcomes. We are dedicated to redefining radiology excellence through our cutting-edge technology and solutions. Our mission is to enhance patient care and improve diagnostic accuracy. Join us...


  • Delhi, Delhi, India Polymed Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Job Location: DelhiKey ResponsibilitiesPrepare, review, and maintain regulatory documentation (dossiers, registration files, certificates, product information, etc.)Coordinate with sales & marketing team to collect required documents and information for product registrations and submissions.Liaise with the factory regulatory department to ensure timely...


  • Delhi, Delhi, India LegalRaasta Technologies Pvt Ltd Full time ₹ 4,20,000 - ₹ 5,40,000 per year

    We are seeking a Senior Regulatory Affairs Executive with strong expertise in medical devices. The role involves handling end-to-end regulatory compliance, preparing and submitting dossiers, coordinating with CDSCO, managing product approvals, and ensuring adherence to medical device regulations. Candidate should have good knowledge of MDR, BIS, ISO 13485,...


  • Delhi, Delhi, India Curiza LIfeciences Pvt. Ltd. Full time ₹ 60,00,000 - ₹ 1,00,00,000 per year

    Job Role: International Regulatory AffairsResponsible for compilation & submission of Dossier of a generic drug.Hand on experience in Filing dossiers to regulated, emerging and ROW markets.Experienced in CTD/ACTD and Regional Module.Experience in Filing in EU, ASEAN, MIDDLE EAST AND LATAM regions.To obtain approvals for relevant product marketing,...


  • Delhi, Delhi, India Panacea Biotec Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Position:Sr. Manager / AGM – Regulatory AffairsQualification:M.Sc. / Ph.D. (Life Sciences, Biotechnology, or related discipline)Experience:13–16 years in Regulatory Affairs (vaccines/biologicals)Role:The role is responsible for global product registrations (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and regulatory...


  • Delhi, Delhi, India Beckman Coulter Diagnostics Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Wondering what's within Beckman Coulter Diagnostics? Take a closer look.At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds,...


  • Delhi, Delhi, India Wonder Products Group of Companies Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Seeking Compliance & Regulatory Affairs Manager (5+ yrs exp) at Wonder Products, NSP Delhi. Ensure global/domestic compliance, manage submissions, labeling & audits. Apply now