Senior Regulatory Affairs Professional

5 days ago

Bellary, Karnataka, India beBeeRegulatoryAffairs Full time US$ 90,000 - US$ 1,20,000
Regulatory Affairs Specialist

We are seeking an experienced Regulatory Affairs professional to join our team.

  • Job Summary:

Our ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.

  • Key Responsibilities:
  • Preparation of Regulatory Filings: The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines).
  • Compliance Management: Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
  • Regulatory Interactions: Interacted with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) during product submissions, inspections, and audits.
  • Regulatory Strategies: Developed and maintained regulatory strategies to support new product development and lifecycle management.
  • Product Compliance: Reviewed labeling, promotional materials, and product packaging for compliance with applicable regulations.
  • Knowledge Management: Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
  • Quality Systems: Supported quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
  • Cross-Functional Collaboration: Collaborated with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
  • Regulatory Support: Assisted in responding to regulatory queries, deficiency letters, and inspection findings.
  • Documentation Management: Managed regulatory documentation archives and maintained compliance records for audits and inspections.

Required Skills and Qualifications:

  • Strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration.

Benefits:

  • Opportunity to work with a dynamic team.

Others:

  • This is a unique opportunity to make a difference in the industry.

  • Regulatory Affairs Specialist

    12 hours ago

    Bellary, Karnataka, India beBeeSpecialist Full time ₹ 15,00,000 - ₹ 25,00,000

    About the RoleThe Regulatory Affairs team plays a pivotal role in navigating India's complex regulatory environment and ensuring alignment with business objectives.This team works closely with government bodies, regulatory departments, and other stakeholders to drive business success.Provide strategic guidance on policy strategies that align with business...

  • Senior Regulatory Affairs Expert

    4 days ago

    Bellary, Karnataka, India beBeeCompliance Full time ₹ 18,00,000 - ₹ 24,00,000

    Regulatory Affairs SpecialistThis is a senior position in the regulatory affairs team responsible for managing CMC activities related to US FDA submissions, including ANDA preparation, review and filing.Lead and manage cross-functional teams to gather required documentation and data.Review and ensure compliance of batch manufacturing records (BMR), process...

  • Senior Regulatory Compliance Manager

    1 week ago

    Bellary, Karnataka, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 25,00,000

    Job Overview:We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. This individual will be responsible for managing CMC regulatory activities for USFDA submissions, including ANDA preparation, review, and filing.

  • Regulatory Intelligence Specialist

    3 days ago

    Bellary, Karnataka, India beBeeRegulatory Full time ₹ 60,00,000 - ₹ 80,00,000

    About Regulatory Intelligence SpecialistOur organization empowers companies to enhance product quality and stay ahead of evolving regulations. We leverage one of the industry's most comprehensive datasets, sourced from hundreds of health agencies and records.About the RoleYou will play a critical role in monitoring and analyzing the global regulatory...

  • Regulatory Compliance Specialist

    5 days ago

    Bellary, Karnataka, India beBeeCompliance Full time ₹ 7,00,000 - ₹ 14,50,000

    Job OverviewTo ensure timely submission of returns to regulatory authorities.Conduct AML transaction monitoring and review risk categorization of customers.Assist in compliance reviews and monitoring across various departments.Handle communications with regulatory bodies.Prepare MIS dashboards for strategic decision-making.This role involves ensuring...

  • Digital Finance Regulatory Expert

    5 days ago

    Bellary, Karnataka, India beBeeLawyer Full time US$ 9,00,000 - US$ 15,00,000

    Job Overview:We are seeking a seasoned Legal Manager to join our team and play a pivotal role in managing our legal and regulatory affairs.Key Responsibilities: Advise on, draft, review, negotiate, and close a variety of commercial agreements including third-party contracts, service agreements, partnerships, and license agreements.Support general corporate...

  • Highly Skilled Financial Regulatory Professional

    5 days ago

    Bellary, Karnataka, India beBeeSenior Full time ₹ 1,80,00,000 - ₹ 2,25,00,000

    **Job Overview**We are seeking highly skilled professionals who embody the highest standards of integrity, professionalism, and respect in every interaction.The successful candidate will play a senior role within our Financial Regulatory Practice, leading complex client engagements across regulatory supervision, policy formulation, risk management,...

  • Lead Medical Affairs Strategist

    6 hours ago

    Bellary, Karnataka, India beBeeMedicalAffairs Full time ₹ 15,00,000 - ₹ 30,00,000

    The General Manager role leads the medical affairs strategy, focusing on providing robust support and facilitating collaboration between teams.Medico-marketing Support:Provide medical references to support product positioning and development.Marketing Collaboration:Support the marketing team with strategic advice on promotional activities.Material...

  • Innovative Medical Devices Lead

    6 days ago

    Bellary, Karnataka, India beBeeDeviceEngineering Full time ₹ 15,00,000 - ₹ 20,00,000

    Senior Device EngineerThe role of Senior Device Engineer requires a highly skilled and experienced professional to lead the development and implementation of innovative medical devices.Key Responsibilities:Apply knowledge of regulatory standards to ensure compliance with ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and MDR 2017/745.Expertise...

  • Regulatory Compliance Professional

    2 days ago

    Bellary, Karnataka, India beBeeCompliance Full time ₹ 90,00,000 - ₹ 1,25,00,000

    Job Opportunity: Compliance SpecialistWe are seeking an experienced and skilled Compliance Specialist to join our organization.Key Responsibilities:Compliance Audit and Review: Conduct thorough reviews and maintain documentation to ensure adherence to regulatory requirements and internal standards.Corporate Governance Analysis: Evaluate the organization's...