Lead, Regulatory Affairs

6 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 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...

  • Regulatory Affairs

    2 weeks ago

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

    Area Of ResponsibilityTo review quality and manufacturing end data for various in-house developed APIs for regulatory adequacy for compilation of Drug Master Files/Registration Dossiers, Amendments/Variations, Technical Data Package/Open Parts of DMFs for In-House developed APIs and their updation to meet current regulatory requirements.To review outsourced...

  • Medical Affairs Lead

    1 week ago

    Gurgaon, Haryana, India Maxima Executive Search Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    About the Role:We are seeking an experienced and strategic Medical Affairs Lead. The ideal candidate will be a post-graduate (MD) in Pharmacology with a strong background in medical affairs, medico-marketing, and clinical research within the Nutrition, Pharmaceutical or Consumer Healthcare industries. This role requires a professional with a proven track...

  • 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 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

    3 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...

  • DRA (Drag Regulatory Affair) Assistant Manager

    5 hours ago

    Gurgaon, Haryana, India Bal Pharma Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Roles and Responsibilities (5 days working)Manage regulatory dossiers for solid oral products, including CTD and ACTD preparation and submission to global markets.Handle team responsibilities related to dossier compilation, review, and approval.Ensure compliance with GMP regulations and provide guidance on regulatory affairs matters within the...

  • Senior Regulatory Affairs Manager

    2 weeks ago

    Gurgaon, Haryana, India Glanbia Performance Nutrition Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    We are seeking a highly experienced and detail-oriented Regulatory Affairs professional to manage regulatory compliance for our Sports Nutrition portfolio across India and international markets. This individual contributor role involves reviewing product formulations, labels, and claims, ensuring alignment with FSSAI and global regulatory frameworks, and...

  • Regulatory Affairs

    1 week ago

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

    The role is to assist in providing the regulatory administration activities of regional regulatory function. This position is responsible for organizing, revising and maintaining all regulatory documents within the regulatory department. The individual will assist in the registration of products by preparing and submitting documentation needed for...