Lead, Regulatory Affairs

1 day ago

Gurgaon Haryana, India BOSTON SCIENTIFIC Full time

Additional Locations N A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At 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 information and training we ll help you in advancing your skills and career Here you ll be supported in progressing - whatever your ambitions Location Gurugram India Key Responsibilities 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 Requirements Graduate Postgraduate in any life sciences Engineering 8 years of relevant experience Requisition ID 614765 As a leader in medical science for more than 40 years we are committed to solving the challenges that matter most - united by a deep caring for human life Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives create value for our customers and support our employees and the communities in which we operate Now more than ever we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen So choosing a career with Boston Scientific NYSE BSX isn t just business it s personal And if you re a natural problem-solver with the imagination determination and spirit to make a meaningful difference to people worldwide we encourage you to apply and look forward to connecting with you

  • 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...

  • Assistant Manager- Regulatory Affairs

    5 days ago

    Gurgaon, Haryana, India Johnson & Johnson Full time

    At Johnson Johnson we believe health is everything Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented treated and cured where treatments are smarter and less invasive and solutions are personal Through our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full...

  • Associate- Regulatory Affairs

    6 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...

  • Deputy Manager Regulatory Affairs

    1 week ago

    Gurgaon, Haryana, India Haleon Full time

    Hello We re Haleon A new world-leading consumer health company Shaped by all who join us Together we re improving everyday health for billions of people By growing and innovating our global portfolio of category-leading brands - including Sensodyne Panadol Advil Voltaren Theraflu Otrivin and Centrum - through a unique combination of deep human understanding...

  • Head Of Public Policy And Regulatory Affairs India

    3 weeks ago

    Gurgaon, Haryana, India Maersk Full time

    At Maersk we believe in an integrated world Connected all the way We provide our customers with a simple end-to-end offering of products and services through a superior delivery network at sea on land and in the air taking the complexity out of supply chains and thereby improve the flow of foods goods data and materials to sustain people businesses and...

  • Associate - Regulatory Affairs

    18 hours ago

    Gurugram, Haryana, India DDReg Pharma Full time

    -Full Time Gurgaon Posted 5 days ago Job title Associate - Regulatory Affairs - Reports to Senior Associate/Astt Manager/Manager - Regulatory Affairs - **Job purpose**: To carry out Regulatory Review and Compilation of Technical documentation & dossiers for - Various Markets in compliance to applicable regulations and guidelines. - **Duties and...

  • Dgm/sm - Regulatory Affairs - Cmc - Branded

    1 day ago

    Gurgaon, Haryana, India Sun Pharmaceutical Industries Full time

    Job Title Sr Manager DGM Business Unit Sun Global Operations Job Grade G9A G8 Location Gurgaon At Sun Pharma we commit to helping you Create your own sunshine - by fostering an environment where you grow at every step take charge of your journey and thrive in a supportive community Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world...

  • Regulatory Affairs Intern

    2 weeks 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

    6 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...

  • Regulatory Affairs Professional

    4 days ago

    Gurgaon, India Siemens Healthineers Full time

    **Internal Title**:Regulatory Affairs Professional **External Title**:Deputy General Manager **Position Summary** This position is primarily responsible to ensure pre market & post market compliance to Medical Device Rules(MDR) 2017 governed by Central Drug Standard Control Organization (CDSCO) & state FDA for SHPL's diagnostic imaging & therapy medical...