CMC Regulatory Compliance Specialist

7 days ago

Mysore, Karnataka, India beBeeRegulatoryAffairs Full time ₹ 12,00,000 - ₹ 15,00,000
Job Description:

As a Senior Regulatory Affairs Specialist, you will lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing.

Key Responsibilities:
  • Manage the compilation and submission of Annual Reports, amendments, and deficiency responses to ensure compliance with regulatory requirements.
  • Collaborate with cross-functional teams including Quality Assurance, Production, and R&D to gather required documentation and data.
  • Review and ensure compliance of Batch Manufacturing Records (BMR), process validation documents, and site-related data.
  • Coordinate with manufacturing units to ensure product and process compliance aligned with regulatory requirements.
  • Stay updated on evolving USFDA regulations and provide impact assessment and strategic guidance.
Required Skills and Qualifications:
  • A minimum of 7-10 years of hands-on experience in Regulatory Affairs – CMC with USFDA filings (especially ANDAs).
  • A 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.
Benefits:

This role requires a highly skilled professional who can ensure compliance with regulatory requirements while providing strategic guidance to the team.

  • A Regulatory Compliance Expert Role

    21 hours ago

    Mysore, Karnataka, India beBeeCompliance Full time ₹ 25,00,000 - ₹ 30,00,000

    Regulatory Compliance SpecialistYou will play a pivotal role in ensuring our organization's adherence to all applicable statutory, regulatory, and internal governance requirements.Compliance Audit and Reporting: Conduct thorough reviews, maintain comprehensive documentation, and ensure adherence to regulatory requirements and internal standards.Corporate...

  • Regulatory Compliance Expert

    3 days ago

    Mysore, Karnataka, India beBeeRegulatory Full time ₹ 13,00,524 - ₹ 16,40,626

    Job Title: Regulatory Compliance ExpertWe are seeking an experienced professional to fill the role of Regulatory Compliance Expert.About the Role:The successful candidate will have expertise in both pharmaceutical and medical device regulatory compliance. The primary responsibility will be preparing, reviewing, and submitting regulatory documentation to...

  • Chief Regulatory Compliance Specialist

    3 days ago

    Mysore, Karnataka, India beBeeRegulatory Full time ₹ 40,00,000 - ₹ 50,00,000

    Compliance Officer Job OverviewThis role entails ensuring adherence to RBI and SEBI regulations, supporting governance processes, managing audits and inspections, and providing compliance guidance to senior leadership and board-level committees.Key responsibilities include continuously tracking and evaluating regulatory updates relevant to the organization,...

  • Senior Regulatory Specialist

    3 days ago

    Mysore, Karnataka, India beBeeRiskManagement Full time ₹ 2,50,00,000 - ₹ 3,00,00,000

    Our goal is to hire individuals who demonstrate the highest standards of integrity, showcase professionalism in every interaction, treat others with respect and consistently align their personal ambitions with the collective goals of the organization.**Job Description:**The Senior Regulatory Specialist will play a senior role within the Financial Regulatory...

  • Financial Compliance Specialist

    3 days ago

    Mysore, Karnataka, India beBeeCompliance Full time ₹ 40,00,000 - ₹ 80,00,000

    Job Title: Financial Compliance SpecialistWe are seeking a skilled professional to manage financial transactions, ensure compliance with regulatory requirements and optimize financial performance.Key Responsibilities:Coordinate the preparation and submission of financial statements and statutory filings in adherence to regulatory standards.Monitor and...

  • Regulatory Compliant Document Specialist

    3 days ago

    Mysore, Karnataka, India beBeeClinicalResearch Full time ₹ 15,00,000 - ₹ 25,00,000

    Clinical Study SpecialistTransforming complex scientific data into regulatory compliant documents is a key responsibility in this role. Documents such as protocols, Investigator's Brochures (IBs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), and Clinical Study Reports (CSRs) require high-quality development to drive drug development and...

  • Compliance Specialist

    3 days ago

    Mysore, Karnataka, India beBeeGrc Full time ₹ 9,00,000 - ₹ 18,00,000

    Aurex is seeking a Compliance Specialist. The ideal candidate will be an integral member of our team, responsible for implementing GRC systems that ensure policy compliance, security requirements governance, and risk management.Responsibilities:Develop and participate in the implementation of client initiatives focused on reducing technology risk, improving...

  • Business Compliance Strategist

    3 days ago

    Mysore, Karnataka, India beBeeCompliance Full time US$ 55,000 - US$ 83,000

    Business Compliance SpecialistWe are seeking a dedicated business compliance specialist to assist companies with their business formation and registration processes in the USA. This role involves handling federal registrations, state and local tax registrations, payroll setups, and managing ongoing regulatory compliance.This includes assisting clients with...

  • Senior Financial Compliance Specialist

    5 days ago

    Mysore, Karnataka, India beBeeFinancialCompliance Full time ₹ 10,00,000 - ₹ 14,00,000

    Senior Financial Compliance SpecialistThe role of Senior Financial Compliance Specialist involves overseeing audit engagements, evaluating financial statements and ensuring adherence to regulatory requirements. Effective collaboration with clients is crucial in addressing audit findings and handling independent assignments.Key Responsibilities:Oversee audit...

  • Strategic Corporate Compliance Lead

    3 days ago

    Mysore, Karnataka, India beBeeCompliance Full time ₹ 90,00,000 - ₹ 1,20,00,000

    Job Title: Business Compliance and Registration SpecialistCompanies seeking strategic guidance on business registrations, state tax registrations, payroll registrations, and ongoing statutory compliance in India can rely on a dedicated compliance specialist.The role demands meticulous attention to detail, comprehensive understanding of Indian corporate laws,...