Lead, Regulatory Affairs

4 days ago

Gurgaon, Haryana, India Boston Scientific Full time ₹ 8,33,333 - ₹ 25,00,000 per year

Compilation of Medical Device Dossier w.r.t Indian regulatory requirements for Registration, Clinical Trial Permissions, License Transfers, Import License, New Product Approvals, Renewals Regular follow-ups with CDSCO Work with other regulatory authorities like Atomic Energy Review Board (AERB), Department of Telecommunication (DoT), Legal Metrology, etc. Framework: Medical Write-ups and Executive summaries Addressing Technical Queries both from regulators and internal stakeholders Change Management including tracking and submission of product/ site changes Acquisition related submissions, project planners and follow-ups Preparation of Technical literature/ presentation(s) w.r.t. Subject Expert Committee meetings Communicate new local requirement/ new product registration / update in labelling information/ update in MRP to labelling team and ensure correctness in label release. Application for new warehouse license or amendment in the existing warehouse license Applies understanding of business acumen and stakeholder management to accomplish the project Demonstrates knowledge of the company, processes and customers Uses prescribed guidelines or policies in analyzing situations and resolving problems to deliver continuous business results Provide informal guidance to team members Regulatory Compliance Management: Mapping imports with existing approvals Mapping current practices with existing regulations Graduate/Postgraduate in any life sciences/Engineering 8+ years of relevant experience

  • Associate- Regulatory Affairs

    2 days ago

    Gurgaon, Haryana, India DDReg Pharma Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    DDReg PharmaDDReg PharmaFull TimeGurgaonPosted 14 minutes agoJob Purpose:We 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...

  • Senior Manager-Regulatory Affairs-EU/US

    2 weeks ago

    Gurgaon, Haryana, India DDReg Pharma Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Full TimeGurgaonPosted 4 hours agoSr. Manager-Regulatory Affairs- US/EUExperience: -15+ YearsLocation: GurgaonWe are looking for an experienced and accomplished Senior Manager – Regulatory Affairs (CMC) with deep expertise in US and EU regulatory frameworks. The role will drive regulatory strategy, dossier submissions, and lifecycle management activities...

  • Regulatory Affairs Intern

    1 week ago

    Gurgaon, Haryana, India Philips Full time ₹ 4,00,000 - ₹ 6,00,000 per year

    Job TitleRegulatory Affairs InternJob DescriptionYour role:Tracking and establishing Process of PC& PNDT (Pre Conception & Pre Natal Diagnostic Techniques) regulations at the District / State level for the sale / supply / demonstration of medical devices that come under PC& PNDT regulations.Tracking and establishing Process of AERB (Atomic Energy Regulatory...

  • Regulatory Affairs Associate

    2 days ago

    Gurgaon, Haryana, India DDReg Pharma Pvt. Ltd. Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    JOB PURPOSE:We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support globalregulatory 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...

  • Drug Regulatory Affairs Specialist

    2 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...

  • Lead, Regulatory Affairs

    3 hours ago

    Gurgaon, Haryana, India Boston Scientific Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Additional Locations:N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools,...

  • Associate- Drug Regulatory Affairs_US_

    3 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...

  • Associate- Drug Regulatory Affairs_Canada_

    4 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...

  • Regulatory Affairs

    2 days ago

    Gurgaon, Haryana, India Vivchar Global Full time ₹ 40,00,000 - ₹ 1,20,00,000 per year

    Responsibilities:* Prepare regulatory dossiers for product approvals* Collaborate with cross-functional teams on dossier updates* Ensure compliance with drug regulations according to NAFDAC standards.* Manage LOAs, COAs & BDNAF submissions

  • Manager - Aeropolitical Affairs

    1 week ago

    Gurgaon, Haryana, India IndiGo (InterGlobe Aviation Ltd) Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Manager – Aeropolitical AffairsReporting to: Senior Manager – Aeropolitical & Industry AffairsThe Manager – Aeropolitical Affairs will be responsible for supporting the Department in expanding traffic rights and market access for IndiGo and will also be responsible for ensuring adherence to regulatory requirements as required to expand and maintain...