Talent.com
This job offer is not available in your country.
Urgent! Regulatory Affairs Executive

Urgent! Regulatory Affairs Executive

Halma plcIndia
12 hours ago
Job description

About Halma :

Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US.

Our diverse group of nearly 50 global companies specialise in market leading technologies that push the boundaries of science and technology.

For the last 42 years, the combination of our purpose, strategy, people, DNA and sustainable business model has resulted in record long-term growth in revenues and profits and an increase in dividend by ≥ 5% every year– an achievement unrivalled by any company listed on the London Stock Exchange.

Why join us?

We are a Great Place to Work® certified organisation, with an employee centric culture anchored on autonomy, trust, respect, humility, work-life balance, team spirit, and approachable leadership.

We offer a safe and respectful workplace, where everyone can be who they ‘REALLY’ are, feel free to bring their whole selves to work and use their unique talents, knowledge, expertise, experiences, and backgrounds to create meaningful outcomes.

We nurture entrepreneurial spirits and empower them to think beyond the possibilities, to discover, shape and build their own unique stories. We promote and support non-linear career growth for the right talent.

We are simple, humble and approachable, and we believe in leadership at all levels to bring our purpose to life. Everyone at Halma India makes an impact, and so do you when you join us!

Responsibilities :

  • Have regular meetings with international Regulatory Teams of Halma Companies to understand their evolving business needs wrt Indian market.
  • Assist them in understanding the India MDR with clarity.
  • Serve as a consultant, advisor and guide to the International Regulatory team with a solution orientation.
  • Reach out to CDSCO or travel to Delhi for mtg with regulatory officers to seek clarification.
  • Tap into External India MDR Consultant as and when required.
  • Evaluate, Recommend, Implement and Use technology and platforms to manage licences and process flows for multiple Operating Companies within the Group.
  • Minimise risk to business disruption from regulation.
  • Agile and responsive to changing regulatory environment and evolving business needs.
  • Use MTAI membership effectively for advocacy as well as position Halma’s point of view whenever required.
  • In addition, there are regulatory license applications for PESO to be also managed with a list of documents.
  • GEM portal registration for Halma companies based abroad including providing checklist, outlining process, following up for documents, submission of the same, and facilitating online video audits of the factories.

Critical Success factors :

  • Executional Rigor, Due diligence wrt to Documentation, and Process Oriented for day-to-day MDR Licensing requirement.
  • Understands varying needs across diverse stakeholders – especially different types of medical devices.
  • Transparent and effective communicator with all stakeholders, and commercially savvy when recommending solutions.
  • Deep and Clear understanding of evolving India MDR.
  • Qualifications :

  • Degree in Regulatory Management.
  • Experience :

  • Minimum 1 to 3 years of relevant experience.
  • Core end-to-end experience in India MDR.
  • Experience in Regulatory License platforms.
  • Exposure to Legal Metrology & Labelling, UDI, MRP / Pricing / Trade Margins, Customs and other related operational issues.
  • Exposure to European MDR and FDA would be advantageous.
  • Create a job alert for this search

    Executive • India

    Related jobs
    • Promoted
    Validation Lead

    Validation Lead

    Compliance Group IncNagpur, IN
    We are looking for Validation Lead for Compliance Group Inc.High preference to short notice period.Develop and implement validation strategies and processes to ensure the quality and reliability of...Show moreLast updated: 30+ days ago
    • Promoted
    Manager Global Regulatory Affairs

    Manager Global Regulatory Affairs

    Biocon BiologicsIndia
    Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects.Developme...Show moreLast updated: 19 days ago
    • Promoted
    Regulatory Affairs Excellence Specialist

    Regulatory Affairs Excellence Specialist

    PhilipsIndia
    Job Responsibilities Implements global regulatory strategies and roadmaps by leveraging a comprehensive understanding of the competitive market landscape and product marketing strategy to ensure al...Show moreLast updated: 14 days ago
    • Promoted
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    Frisch Medical Devices PVT LTDIndia
    Job Title : Regulatory Affairs Junior Manager.Location : At Ahmedabad Office , Near Thaltej Crossroads.Reports To : RA Head and Regulatory Department at HO / Director. Office hours : 9,30 AM to 6 PM.Wee...Show moreLast updated: 30+ days ago
    • Promoted
    Regulatory Affairs Executive

    Regulatory Affairs Executive

    Biotech HealthcareIndia
    Key objective of this role is to prepare, review, and maintain regulatory documents to ensure compliance with international guidelines and country-specific requirements. The role involves coordinati...Show moreLast updated: 30+ days ago
    • Promoted
    Regulatory Affairs Executive

    Regulatory Affairs Executive

    Halma plcIndia
    About Halma : Halma is a global group of life-saving technology companies, driven by a clear purpose.We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including ...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Manager Regulatory Affairs

    Senior Manager Regulatory Affairs

    Panacea BiotecIndia
    Manager / AGM – Regulatory Affairs Qualification : .Life Sciences, Biotechnology, or related discipline) Experience : .Regulatory Affairs (vaccines / biologicals) Role : The role is responsible for global...Show moreLast updated: 22 days ago
    • Promoted
    Assistant Manager - Regulatory Affairs (US Market) / Formulations OSD

    Assistant Manager - Regulatory Affairs (US Market) / Formulations OSD

    Jubilant Generics LimitedIndia
    Drug dossier authoring, reviewing & submission drug product application.Management of product life cycle management (LCM) activities. Assessment of post approval changes to secure successful product...Show moreLast updated: 22 days ago
    • Promoted
    Regulatory Compliance Manager

    Regulatory Compliance Manager

    AIMS OXYGEN PRIVATE LIMITEDIndia
    Company Description AIMS OXYGEN PRIVATE LIMITED (AOPL) is an industrial and medical gases company with over 61 years of business experience. Based in Vadodara, AOPL has grown from a small air separa...Show moreLast updated: 9 days ago
    • Promoted
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    Biocon BiologicsIndia
    Job Summary : Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspe...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Chief Validation Officer

    Chief Validation Officer

    beBeeValidationNagpur, Maharashtra, India
    We are seeking a Validation Lead to spearhead quality and reliability initiatives.The successful candidate will lead cross-functional teams in defining validation requirements and priorities.The id...Show moreLast updated: 14 hours ago
    • Promoted
    Regulatory Compliance Specialist -2+

    Regulatory Compliance Specialist -2+

    Jupiter AI LabsNagpur, IN
    Regulatory & Compliance Specialist.India and international destination countries.This role is ideal for professionals experienced in handling regulatory filings, certifications, and export-related ...Show moreLast updated: 14 days ago
    • Promoted
    Regulatory Affairs Manager

    Regulatory Affairs Manager

    Kimirica Hunter InternationalIndia
    Manager – Regulatory and Compliance Location : .Role Overview : Kimirica Hunter International is seeking a highly skilled. Manager – Regulatory and Compliance.The ideal candidate will bring extensive e...Show moreLast updated: 14 days ago
    • Promoted
    • New!
    ▷ (Only 24h Left) Manager Global Regulatory Affairs

    ▷ (Only 24h Left) Manager Global Regulatory Affairs

    Biocon BiologicsIndia
    Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects.Developme...Show moreLast updated: less than 1 hour ago
    • Promoted
    Assistant Manager Regulatory Affairs

    Assistant Manager Regulatory Affairs

    Forest EssentialsIndia
    JOB TITLE- ASSISTANT MANAGER (REGULATORY AFFAIRS).DEPARTMENT- REGULATORY AFFAIRS.INDUSTRY- PERSONAL CARE - COSMETICS / AYURVEDIC. ROLE- TECHNICAL REGULATORY AFFAIRS.Review Product formulation as per...Show moreLast updated: 14 days ago
    • Promoted
    Regulatory Affairs Officer

    Regulatory Affairs Officer

    A.P. Moller - MaerskIndia
    Moller - Maersk is an integrated container logistics company working to connect and simplify its customers’ supply chains. As the global leader in shipping services, the company operates in 130 coun...Show moreLast updated: 19 days ago
    • Promoted
    Regulatory Operations

    Regulatory Operations

    Airtel Payments BankIndia
    Purpose of the Job This is a Subject Matter expertise profile which requires a detail-oriented and experienced Regulatory Reporting professional to join our team. The ideal candidate will have a str...Show moreLast updated: 30+ days ago
    Associate Director-Regional Regulatory Associate

    Associate Director-Regional Regulatory Associate

    Eli LillyIN
    At Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work...Show moreLast updated: 11 days ago
    • Promoted
    • New!
    ▷ 15h Left : Regulatory Compliance Manager

    ▷ 15h Left : Regulatory Compliance Manager

    AIMS OXYGEN PRIVATE LIMITEDIndia
    AIMS OXYGEN PRIVATE LIMITED (AOPL) is an industrial and medical gases company with over 61 years of business experience.Based in Vadodara, AOPL has grown from a small air separation plant to a mult...Show moreLast updated: less than 1 hour ago
    • Promoted
    • New!
    High Salary : Regulatory Affairs Executive

    High Salary : Regulatory Affairs Executive

    Biotech HealthcareIndia
    Key objective of this role is to prepare, review, and maintain regulatory documents to ensure compliance with international guidelines and country-specific requirements. The role involves coordinati...Show moreLast updated: less than 1 hour ago