Senior regulatory specialist

4 days ago

Gurgaon, India SUN PHARMA Full time

We're hiring Looking for an energetic Regulatory Affairs professionals join our team in Gurgaon.Job SummaryRegulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals.Area Of Responsibility1. New submissions:a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy.2. Approval : Review & prepare response to deficiency enabling approval of products filed to regulatory agency.3. Lifecycle management for drug formulations:a. Prepare and review variation , Annual notification and labelling approval for US and OAMb. Review of change control and file variation as per country requirement4. Regulatory compliance:a. e CTD compilationb. Ensure reposition of comprehensive product information into central repository C. Review regulatory filing impact of variations, change controls, etc.

  • Senior Regulatory Specialist

    5 days ago

    Gurgaon, India SUN PHARMA Full time

    We're hiring!! Looking for an energetic Regulatory Affairs professionals join our team in Gurgaon. Job Summary Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals. Area Of Responsibility 1. New submissions: a. Review & prepare CMC...

  • Senior Regulatory Specialist

    1 week ago

    Gurgaon, Haryana, India SUN PHARMA Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    We're hiring Looking for an energetic Regulatory Affairs professionals join our team in Gurgaon.Job SummaryRegulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals.Area Of ResponsibilityNew submissions:a. Review & prepare CMC...

  • Senior Regulatory Specialist

    4 days ago

    Gurgaon, India SUN PHARMA Full time

    We're hiring!! Looking for an energetic Regulatory Affairs professionals join our team in Gurgaon.Job SummaryRegulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals.Area Of Responsibility1. New submissions:a. Review & prepare CMC...

  • Senior Regulatory Specialist

    3 days ago

    Gurgaon, India SUN PHARMA Full time

    We're hiring!! Looking for an energetic Regulatory Affairs professionals join our team in Gurgaon.Job SummaryRegulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals.Area Of Responsibility1. New submissions:a. Review & prepare CMC...

  • Senior regulatory specialist

    4 days ago

    Gurgaon, India SUN PHARMA Full time

    We're hiring!! Looking for an energetic Regulatory Affairs professionals join our team in Gurgaon.Job SummaryRegulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals.Area Of Responsibility1. New submissions:a. Review & prepare CMC...

  • Drug Regulatory Affairs Specialist

    6 days ago

    Gurgaon, Haryana, India Sam Global Bio care Pvt. Ltd. Full time ₹ 3,00,000 - ₹ 3,60,000 per year

    Company: Sam Global Biocare Pvt. Ltd.Location: Gurgaon (Gurugram), Sector 67, HaryanaJob Description:Sam Global Biocare Pvt. Ltd. is looking for a skilled Drug Regulatory Affairs Specialist with a strong understanding of international regulatory guidelines. Our focus is on exporting to the Middle East and expanding into African markets, so familiarity...

  • Associate- Drug Regulatory Affairs_Canada_

    7 days ago

    Gurgaon, Haryana, India DDReg Pharma Pvt. Ltd. Full time US$ 60,000 - US$ 1,20,000 per year

    Job PurposeWe are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier preparation, particularly for Canada Markets.Key...

  • Associate- Drug Regulatory Affairs_US_

    7 days ago

    Gurgaon, Haryana, India DDReg Pharma Pvt. Ltd. Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Job PurposeWe are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier preparation, particularly for US Markets.Key...

  • Regulatory Reporting Operations Specialist

    7 days ago

    Gurgaon, Haryana, India Innova AM Tech Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    LocationGurgaon- DepartmentRegulatory Reporting / Client Services- Job Summary:- We are seeking a highly skilled and motivated Regulatory Reporting Solutions Specialist to manage and address regulatory inquiries, support daily reporting challenges, and aid in the resolution of technical issues across various global markets.- The ideal candidate will possess...

  • Associate- Regulatory Affairs

    4 days ago

    Gurgaon, Haryana, India DDReg Pharma Pvt. Ltd. Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    Job PurposeWe are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier preparation, particularly for EU and emerging markets.Key...