Expert Regulatory Affairs Specialist

3 days ago


Cochin, Kerala, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 20,00,000

Regulatory Compliance Expert

  • We seek an experienced professional to lead and manage CMC regulatory activities for USFDA submissions.
  • This role involves overseeing the compilation and submission of Annual Reports, amendments, and deficiency responses.
  • You will interface with cross-functional teams including Quality Assurance, Production, and R&D to gather required documentation and data.
  • Your responsibility will include reviewing and ensuring compliance of Batch Manufacturing Records (BMR), process validation documents, and site-related data.
  • You will coordinate with manufacturing units to ensure product and process compliance aligned with regulatory requirements.
  • Staying updated on evolving USFDA regulations is crucial in this role, where you will provide impact assessment and strategic guidance.

Requirements

  • A minimum of 7–10 years of hands-on experience in Regulatory Affairs – CMC with USFDA filings, particularly ANDAs.
  • Strong understanding of ICH, USFDA guidelines, and regulatory frameworks applicable to generic drug products.
  • Experience in preparing and reviewing technical documents: Module 2 & 3 (CTD format).
  • Exposure to quality systems, BMR review, and interacting with production/plant teams.
  • The ability to handle end-to-end submission lifecycle, including post-approval changes and correspondence with USFDA.


  • Cochin, Kerala, India beBeeRegulatory Full time ₹ 17,00,000 - ₹ 21,47,483

    Position Overview:We are seeking a detail-oriented professional to support end-to-end submissions for global markets. Required expertise includes Lifecycle Management, Veeva Vault RIM, and complex Initial and Variation submissions.Key responsibilities:Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory...


  • Cochin, Kerala, India beBeeDevice Full time ₹ 20,00,000 - ₹ 25,00,000

    Senior Medical Device ProfessionalJob Overview:We seek a seasoned Senior Medical Device Professional to spearhead our medical devices initiative. The ideal candidate will have an extensive background in medical devices and a proven track record of assessing and auditing medical devices.10+ years of professional experience in the medical devices industry,...


  • Cochin, Kerala, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000

    Job DescriptionWe are seeking an experienced Regulatory Change Monitoring Specialist to join our team. This individual will play a critical role in helping us stay ahead of regulatory changes and ensure compliance with evolving regulations.The successful candidate will be responsible for:Monitoring regulatory updates across multiple jurisdictions,...


  • Cochin, Kerala, India beBeeCompliance Full time ₹ 9,00,000 - ₹ 12,00,000

    Job Title:Compliance ManagerOverview:This role is responsible for leading the organization's compliance programs. The Manager will partner with IT, Legal, Finance, and business teams to identify risks, monitor compliance, and implement controls that protect the organization while enabling innovation and growth.The Compliance Manager ensures that business...


  • Cochin, Kerala, India beBeeLiaison Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    At Notandas Realty, we are on the hunt for an exceptional individual to fill a key role in our organization.We are seeking a seasoned Senior Liaison Officer with a proven track record of success in managing government relations, legal coordination, and regulatory affairs. With over 15 years of experience, this professional will be responsible for fostering...


  • Cochin, Kerala, India beBeeAnaesthesiology Full time ₹ 15,00,000 - ₹ 20,00,000

    Senior Specialist Anaesthesiology Job DescriptionA highly skilled medical professional specializing in providing expert anesthesia care to patients before, during, and after surgical procedures.Key Responsibilities:Evaluate patients' medical history and conduct physical examinations to determine the appropriate anesthesia plan for each individual.Administer...


  • Cochin, Kerala, India beBeeBanking Full time ₹ 1,99,85,900 - ₹ 2,49,95,800

    Job Title:Commercial Banking ProfessionalAbout the Role:We are seeking a seasoned commercial banking consultant to join our team. This individual will act as a solutions expert/advisor, providing strategic insights and domain expertise across commercial banking operations.Main Responsibilities:Act as a domain consultant and advisor in commercial banking...


  • Cochin, Kerala, India beBeeExpert Full time ₹ 3,25,000

    Expert Immigration Support SpecialistWe are seeking an accomplished Immigration Support Specialist to join our team and assist with the coordination of immigration work and case process execution.Develop and review visa application petitions for regulatory compliancePerform quality control and close generic case typesPrepare and verify all immigration...

  • Synology NAS Expert

    2 days ago


    Cochin, Kerala, India beBeeSynology Full time ₹ 8,00,000 - ₹ 12,00,000

    Job Title: Synology NAS ExpertRole OverviewWe are seeking a highly skilled technical professional to provide remote services for the setup and integration of Synology SA3410 NAS units.The specialist will ensure hardware readiness, install and configure the DiskStation Manager (DSM), integrate with Active Directory, create shared folders, apply access...


  • Cochin, Kerala, India beBeeMechanicalEngineering Full time ₹ 20,00,000 - ₹ 25,00,000

    Research and Development EngineerThis role involves working on various aspects of product development, including design quality, mechanical engineering, electrical and electronics engineering, and software engineering.As a Research and Development Engineer, you will be responsible for creating a quality culture by driving compliance activities around...