Regulatory Affairs Expert for Global Product Approvals

6 days ago


Gurgaon, Haryana, India Naari Pharma Pvt Ltd. Full time

Company Overview

N aari Pharma Pvt Ltd. is a leading pharmaceutical company dedicated to delivering innovative healthcare solutions. We are committed to advancing medical science and improving patient outcomes through our cutting-edge products.

About the Role

We are seeking an experienced Regulatory Affairs Specialist to join our team in this key position. As a critical member of our organization, you will play a pivotal role in ensuring compliance with regulatory requirements for our global product approvals.

Responsibilities

  • Global Regulatory Submissions: Manage the full life cycle of regulatory submissions for ROW markets, including initial submissions, query responses, variations, renewals, and post-approval maintenance.
  • Regulatory Dossier Preparation: Independently prepare, compile, and submit high-quality regulatory dossiers that meet country-specific requirements.
  • Regulatory Queries: Address regulatory queries swiftly and accurately, ensuring timely communication and resolution without delays.
  • Regulatory Insights: Provide regulatory insights during new product development to ensure compliance with market-specific requirements.
  • Documentation: Maintain accurate and comprehensive documentation of regulatory activities for audits and future reviews.

Requirements

  • Qualifications: M. Pharma with 5-9 years of relevant experience in Regulatory Affairs, focusing on ROW markets.
  • Skills: In-depth knowledge of regulatory submission processes and life cycle management, strong expertise in responding to complex regulatory queries and handling post-approval changes.
  • Abilities: A proactive, detail-oriented approach with the ability to independently manage multiple projects and deadlines.

What We Offer

A competitive salary of $90,000 - $110,000 per annum, plus benefits, reflecting your value to our organization.



  • Gurgaon, Haryana, India Lifelancer Full time

    About Us: Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT.We're seeking a highly motivated Regulatory Affairs Specialist to support our clients' regulatory needs globally.Job Summary: As an Associate Regulatory Affairs Specialist, you will collaborate with cross-functional teams to ensure successful new product registrations and...


  • Gurgaon, Haryana, India Lifelancer Full time

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Lifelancer, a talent-hiring platform in Life Sciences, Pharma and IT. As an Associate Regulatory Affairs Specialist, you will play a critical role in supporting the Regulatory Affairs function and systems.This is an entry-level position that requires collaboration...


  • Gurgaon, Haryana, India SUN PHARMA Full time

    Job OverviewSun Pharma is seeking an experienced Regulatory Affairs Expert to lead our CMC Product team. In this role, you will be responsible for ensuring timely submission of annual reports and supplements to regulatory authorities.About the RoleWe are looking for a seasoned professional with 10-15 years of hands-on experience in regulatory affairs. You...


  • Gurgaon, Haryana, India Naari Pharma Pvt Ltd. Full time

    We are seeking a skilled Regulatory Affairs Specialist to join our team at Naari Pharma Pvt Ltd.About the RoleThis is a highly rewarding opportunity to utilize your expertise in regulatory affairs and contribute to the growth of our global presence.As a key member of our regulatory team, you will be responsible for managing the entire regulatory life cycle...


  • Gurgaon, Haryana, India Naari Pharma Pvt Ltd. Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Strategist to join our team at Naari Pharma Pvt Ltd.About the RoleThe successful candidate will be responsible for managing the entire regulatory life cycle independently, ensuring timely and accurate submission of regulatory dossiers, and staying up-to-date with changes in regulatory policies and...


  • Gurgaon, Haryana, India Lifelancer Full time

    Job Title: Regulatory Affairs Manager for Global Pharmaceutical ProjectsJob Location: Gurgaon, India or other locations as neededJob Type: Full-timeSalary: ₹ 20-30 LPA based on experience and qualificationsAbout the Role:This is a challenging opportunity to lead global regulatory affairs projects for a pharmaceutical company. As a seasoned professional...


  • Gurgaon, Haryana, India Takeda Full time

    Job Title:Regulatory Affairs Leader - IndiaOverview:Takeda is a pharmaceutical company dedicated to improving the lives of people around the world. We are seeking a Regulatory Affairs Leader to join our team in India. In this role, you will be responsible for leading regulatory strategies and activities to ensure compliance with local...


  • Gurgaon, Haryana, India Naari Pharma Pvt Ltd. Full time

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Naari Pharma Pvt Ltd. in a key role that combines regulatory expertise with market insights.About YouYou have a strong background in pharmaceutical regulatory affairs, with a proven track record of managing the entire regulatory life cycle independently.Your...


  • Gurgaon, Haryana, India Naari Pharma Pvt Ltd. Full time

    Job OverviewWe are seeking an experienced Regulatory Affairs Specialist to join our team at Naari Pharma Pvt Ltd. This role involves managing the entire regulatory life cycle, ensuring compliance with market-specific requirements.


  • Gurgaon, Haryana, India Lifelancer Full time

    About the Role:We are seeking a highly skilled Regulatory Affairs Manager to join our team at Lifelancer, based in Gurugram, Haryana, India. This is a full-time position that offers a competitive salary and exciting opportunities for growth.Job Summary:The successful candidate will be responsible for driving business growth in India by providing regulatory...


  • Gurgaon, Haryana, India Lifelancer Full time

    Job Description:Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek so they can do what they do best: improve the world...


  • Gurgaon, Haryana, India Lifelancer Full time

    Are you a seasoned professional in regulatory affairs looking for a challenging role? Lifelancer is seeking a highly skilled Regulatory Affairs Specialist to join our team in Gurgaon.About the RoleThis exciting opportunity requires a strong background in CMC regulatory leadership, with experience in managing complex projects and working collaboratively with...


  • Gurgaon, Haryana, India Naari Pharma Pvt Ltd. Full time

    Job Overview:Navigate a dynamic regulatory landscape as a skilled Regulatory Affairs Specialist with Naari Pharma Pvt Ltd. Our ideal candidate possesses an in-depth understanding of regulatory frameworks and has a proven track record of independently managing the entire regulatory life cycle.Your Key Responsibilities:Manage the full life cycle of regulatory...


  • Gurgaon, Haryana, India The Hird Full time

    OverviewThe Hird is seeking a detail-oriented Regulatory Affairs Specialist to join our team. In this role, you will be responsible for understanding end-to-end insurance business processes.About the RoleThis is an exciting opportunity to work with our dynamic team and contribute to the growth of The Hird. As a Regulatory Affairs Specialist, you will analyze...


  • Gurgaon, Haryana, India Savanna HR Full time

    Job Title:Compliance SpecialistDescription:We are seeking a seasoned Compliance Specialist to join our team at Savanna HR in Gurgaon. As a key member of our organization, you will be responsible for ensuring timely compliance with all applicable laws and regulations in India and abroad.About the Role:This is an exciting opportunity to work with a dynamic...


  • Gurgaon, Haryana, India Siemens Healthcare Private Limited Full time

    Job Summary:This role is responsible for ensuring pre-market and post-market regulatory compliance for diagnostics and medical devices in India, as well as supporting regulatory requirements in zone countries of Bangladesh, Sri Lanka, Nepal, Bhutan, and Maldives.Key Responsibilities:Interact with local marketing and global RA teams to clarify queries and...


  • Gurgaon, Haryana, India Lifelancer Full time

    We are seeking an experienced Regulatory Affairs Manager to join our team at Lifelancer, a talent-hiring platform in Life Sciences, Pharma and IT.Job Summary:The successful candidate will be responsible for leading and developing regulatory strategies for new products, existing products, and other pipeline molecules of Takeda in accordance with applicable...


  • Gurgaon, Haryana, India Lilly Full time

    OverviewWe are seeking a highly skilled Medical Affairs Professional to join our team at Lilly. As a key member of our organization, you will play a crucial role in delivering strategic and tactical thinking to support the development and commercialization of our products.Job DescriptionThe successful candidate will be responsible for leading medical...


  • Gurgaon, Haryana, India Naari Pharma Pvt Ltd. Full time

    Naari Pharma Pvt Ltd. is a dynamic organization seeking a highly skilled Regulatory Compliance Specialist to join our team.About the Role:We are looking for a seasoned professional with expertise in managing the entire regulatory life cycle, ensuring compliance with market-specific requirements. Your ability to manage projects end-to-end will make you a...


  • Gurgaon, Haryana, India Agilent Full time

    About the RoleAgilent is a leading life science, diagnostic and applied market laboratories company that inspires and supports discoveries to advance quality of life. As an Environmental Regulatory Affairs Specialist, you will play a key role in ensuring our operations, products, and services comply with local, national, and global environmental regulations,...