Lead, Regulatory Affairs

1 week ago


Gurgaon, Haryana, India Boston Scientific Full time ₹ 20,00,000 - ₹ 25,00,000 per year

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.

Job Responsibilities- Mapping of regulatory requirements for functioning of R&D premise.
- Conduct regular gap assessments to identify new regulatory requirements (if any) with regards to functioning of the R&D premises and monitor compliance.
- Ensure compliances to applicable acts and rules viz. Drugs & Cosmetics Act, 1940 and Rules 1945, Medical Device Rules, 2017 and others.
- Identify and support the warehouse licensing requirements (including registration certificate for warehouse)
- Work with R&D teams to identify the requirements for test licenses for importing products for test, evaluation, demonstration or training.
- Strategize, plan and compile test license application and follow up with CDSCO for approval.
- Collaborate with R&D teams to provide regulatory guidance throughout the product development.
- Continuous scanning of the regulatory environment and communication to the R&D team on any new/changing regulations along with impact assessment and mitigation.
- Support R&D team for recognition of in-house R&D units RDI) from Department of Scientific and Industrial Research (DSIR).
- Collaborate with R&D QA team to establish and streamline internal processes.
- Support internal audits and inspections by external agencies (CDSCO/State FDAs/etc.).
- Coordinate with sourcing and warehouse team for importation of goods for R&D purpose and regulatory clarification to ADC/customs, wherever required.
- Compilation of Medical Device Dossier w.r.t Indian regulatory requirements for Registration, 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.
- Addressing Technical Queries both from regulators and internal stakeholders
- Change Management including tracking and submission of product/ site changes
- Applies understanding of business acumen and stakeholder management to accomplish the project
- Uses prescribed guidelines or policies in analyzing situations and resolving problems to deliver continuous business results
- Skills required:

  • Good English Communication Skills – Verbal and Written
  • Problem solving
  • Stakeholder management
  • Software Skills: MS Office
  • Qualification – Graduate/Postgraduate in any life sciences/Engineering
  • Experience – 7-8 years

Requisition ID:
612914

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


  • Regulatory Affairs

    17 hours 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...


  • Gurgaon, Haryana, India Johnson & Johnson Innovative Medicine Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    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...


  • 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...


  • Gurgaon, Haryana, India Intech Organics Limited Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Key Tasks & Responsibilities: Liaising with various Central government ministries like Ministry of Finance, Central Insecticide PPQS, Commerce Ministry, Environment Ministry, Chemical, DIPP, Ministry of Agrochemical, Petrochemical, Coal, Agriculture, Tribal Ministry, Central Insecticide Board, Pollution control Board, Shops & Establishment, Ministry of...


  • Gurgaon, Haryana, India Evergreen Renewables Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    OverviewEvergreen Power is a US-based renewable energy company engaged in developing end-to-end infrastructure, construction and financing of wind and hybrid power projects, in India and US. Team capabilities span over 5000 MW of projects commissioned collectively.Evergreen Renewables is currently offering the position of Manager where you will be playing a...


  • Gurgaon, Haryana, India Sun Pharmaceutical Industries Full time

    The Associate Director Director Global Regulatory Leader Global Regulatory Affairs GRA Specialty Business Brands and Innovative Medicines partners with leaders across the organization to be the face of the asset from a regulatory perspective The role will be responsible for formulating developing and executing a comprehensive regulatory...


  • 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...


  • Gurgaon, Haryana, India Medtronic (Medtronic)(279) Full time

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the Life.Role Summary. The QARA Director for India will be responsible for leading a team supporting Quality...

  • Corporate Affairs

    4 days ago


    Gurgaon, Haryana, India Vrb Consumer Products Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Urgent Hiring for Corporate Affairs /Liaison Manager-GurgaonJob Title: Corporate Affairs / Liaison ManagerLocation: GurgaonCompany Description:VRB Consumer Products Pvt Ltd is a leading condiments and sauce company in India with a strong focus on quality, innovation, and better-for-you products. We have a pan-India distribution network and offer authentic...


  • 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 ...