Global Regulatory Expert

7 days ago


Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Global Regulatory Expert - Clinical and Medical WritingWe are seeking a highly skilled Global Regulatory Expert with expertise in clinical and medical writing. This role is responsible for handling complex projects and providing review support for deliverables that support the regulatory portfolio.This position requires strong knowledge of regulatory guidelines and requirements, as well as excellent communication and interpersonal skills. The ideal candidate will be able to interpret data, apply scientific knowledge, and build clinical or regulatory arguments.The successful candidate will have experience working in document management systems, managing workflows, and adapting to new tools and technology. They will also be able to train writers on the use of templates, guidelines, and tools.This role offers the opportunity to work on a variety of projects, develop expertise in multiple therapeutic areas, and contribute to the growth and success of our organization.Responsibilities:
  • Prepare/review clinical study reports without guidance from senior members of the writing staff.
Requirements:
  • 10-12 years' experience in writing clinical & regulatory documents supporting global filings (CTD Module 2 and Module 5).
  • Strong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the European Union and the United States.
  • Ability to interpret data and apply scientific knowledge to support regulatory document writing.
  • Experience writing protocols, amendments, CSR, and CTD summary documents.
  • Expert authoring in MS Word, understanding of MS Word functionality.
Benefits:

This role offers the opportunity to work with a team that is driven by purpose, passion, innovation, collaboration, and empathy. Our organization provides a unique career experience that celebrates entrepreneurship and offers accelerated, global growth opportunities for talent.

We offer a supportive and dynamic work environment, with opportunities for professional growth and development. Our team is committed to delivering high-quality results and making a positive impact in the healthcare industry.



  • Bengaluru, Karnataka, India beBeeMedicalDevice Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Regulatory Affairs Specialist RoleAs a key player in our regulatory team, you will be instrumental in ensuring compliance of our medical devices with global regulatory requirements. Your primary focus will be on obtaining and maintaining global third-party supplier documentation for Imaging Accessories & Supplies (A&S) products.


  • Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 60,00,000 - ₹ 1,00,00,000

    As a Regulatory Affairs Specialist, you will play a critical role in ensuring our products meet local and international standards. We seek a detail-oriented and proactive professional to support strategies, submissions, and compliance activities across global markets.Key Responsibilities:Regulatory Submissions & Approvals:Prepare, review, and submit...


  • Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 1,00,00,000 - ₹ 1,50,00,000

    Financial Reporting SpecialistWe are seeking an experienced professional to join our Regulatory Reporting team within Control Operations.Develop expert knowledge of regulatory requirements, processes, and systems across global jurisdictions.Perform reconciliation, back-reporting, and exception management as per various regulatory requirements.Investigate and...


  • Bengaluru, Karnataka, India beBeeOperationalRisk Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

    Job SummaryWe are seeking an experienced Senior Manager to lead our Operational Risk and Compliance team. This role will involve providing expert guidance on legal and regulatory frameworks, conducting compliance assessments, and advising on adherence to regulatory requirements.The ideal candidate will have at least 15 years of experience in managing...


  • Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 1,73,37,000 - ₹ 2,53,53,000

    Regulatory Affairs ExpertWe are seeking a highly skilled Regulatory Affairs expert to join our team. As a key member, you will be responsible for driving regulatory intelligence and surveillance initiatives that impact millions of patients worldwide.Key ResponsibilitiesConduct regulatory monitoring, identify key requirements, and maintain awareness of global...


  • Bengaluru, Karnataka, India beBeeregulatory Full time US$ 75,000 - US$ 95,000

    Job OverviewThis role presents an exceptional opportunity to develop skills and contribute to the success of a global biopharma company.You will be accountable for delivering marketing application submissions in compliance with regulatory authority regulations and guidelines. This involves leading relevant teams for product submissions, including renewals,...


  • Bengaluru, Karnataka, India Merck Specialities Pvt. Ltd. Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Your Role:Support and implement CMC Regulatory Intelligence activities (NB this is a non-product specific role):Databases (e.g., CMC Regulatory Country Requirements, Life Cycle Management/Investigational Medicinal Product Catalogues, Wiki-handbook) maintenance and their continuous improvement (including liaison with external data providers, as...


  • Bengaluru, Karnataka, India GlaxoSmithKline Full time

    Accountable to the GRL and Global Regulatory for the delivery of Marketing Application pre-approval investigational and lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices May be responsible for relevant submission team for product...


  • Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 18,00,000 - ₹ 20,40,000

    Regulatory Compliance ProfessionalWe are seeking a seasoned regulatory affairs expert to spearhead the development and implementation of strategic compliance initiatives.The role involves preparing, reviewing, and submitting high-quality regulatory documentation to global health authorities, ensuring seamless compliance with applicable regulations.Key...

  • Global Content Writer

    4 weeks ago


    Bengaluru, Karnataka, India Crescendo Global Full time

    Global Content Writer - Insurance - 3 Years - BangaloreLocation - Bangalore KarnatakaAre you passionate about creating high-quality content that drives business growth and establishes thought leadership Our client is seeking a Content Writer to join their dynamic team and contribute to the development of a global content strategy Your Future Employer A...