Expert Regulatory Affairs Professional

2 days ago


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

Job Title: Regulatory Affairs Expert

We are seeking a seasoned professional to spearhead our regulatory affairs operations, ensuring seamless compliance with pharmaceutical and medical device regulations.

The ideal candidate will be responsible for crafting, reviewing, and submitting high-quality regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.

Key Responsibilities:

  • Crafting regulatory strategies to support new product development and lifecycle management.
  • Maintaining up-to-date knowledge of international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
  • Interacting with regulatory authorities during product submissions, inspections, and audits.
  • Reviewing labeling, promotional materials, and product packaging for compliance with applicable regulations.
  • Managing regulatory documentation archives and maintaining compliance records for audits and inspections.

Requirements:

  • Strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration.
  • Experience with regulatory authorities, such as FDA, EMA, CDSCO, MHRA, and Notified Bodies.
  • Knowledge of international, federal, and local regulatory requirements.
  • Familiarity with quality systems, such as ISO 13485, ICH, and FDA QSR standards.

About Us:

We are dedicated to providing high-quality services in the field of regulatory affairs. Our commitment is to ensuring compliance with applicable regulations and staying up-to-date on the latest industry best practices.



  • Palakkad, Kerala, India beBeeRegulatory Full time ₹ 36,00,000 - ₹ 45,00,000

    Job Title:Senior Regulatory Affairs Specialist",">Manage and lead CMC regulatory activities for USFDA submissions, including ANDA preparation, review, and filing.Oversee the compilation and submission of Annual Reports, amendments, and deficiency responses.Collaborate with cross-functional teams to gather required documentation and data.Review and ensure...


  • Palakkad, Kerala, India beBeeGrowth Full time ₹ 10,00,000 - ₹ 15,00,000

    Government Liaison ManagerThe role of the Government Liaison Manager involves building and maintaining relationships with government officials and regulatory bodies. This includes ensuring compliance with relevant laws and regulations, advocating for the company's interests at the local and state levels, and fostering strong communication, negotiation, and...


  • Palakkad, Kerala, India beBeeRegulatory Full time ₹ 90,00,000 - ₹ 1,20,00,000

    Quality Assurance and Regulatory Affairs ExpertWe seek an experienced professional to oversee quality assurance and regulatory affairs for a leading medical device company.Key Responsibilities:Ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements by conducting thorough risk assessments and implementing corrective actions as...


  • Palakkad, Kerala, India beBeeCompliance Full time ₹ 15,99,999 - ₹ 25,99,999

    Job Title:A Compliance Specialist is required to drive regulatory compliance and risk management initiatives within our organization.This exciting role involves 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...


  • Palakkad, Kerala, India beBeeRegulatory Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

    Job Description">As a seasoned legal professional, you will partner with business and operational teams to drive compliance, innovation, and scalability in a fast-paced mobility environment.Key responsibilities include advising on mobility regulations, drafting commercial agreements, managing consumer litigation, and ensuring compliance with various laws...


  • Palakkad, Kerala, India beBeeData Full time ₹ 60,00,000 - ₹ 90,00,000

    Job Description We are seeking a skilled Data Solutions Coordinator to join our Regulatory Intelligence team. In this role, you will play a critical part in monitoring and analyzing the global regulatory landscape within the life sciences industry. You will be responsible for supporting our regulatory intelligence products and services by actively...


  • Palakkad, Kerala, India beBeeLegal Full time ₹ 1,05,00,000 - ₹ 1,65,00,000

    We are seeking a Legal Professional to oversee our legal and regulatory affairs.Advise on commercial agreements, including third-party contracts, service agreements, partnerships, and license agreements.Support general corporate legal matters with a solid understanding of the Indian Companies Act and related regulations.Develop processes for efficient...


  • Palakkad, Kerala, India beBeeCompliance Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

    Regulatory Change Monitoring SpecialistWe are seeking experienced professionals to support the design and deployment of an AI-driven Regulatory Horizon Scanning solution. These roles focus on leveraging Artificial Intelligence (AI), Natural Language Processing (NLP), and advanced analytics to automatically monitor, interpret, and analyze regulatory updates...


  • Palakkad, Kerala, India beBeeExpert Full time ₹ 20,00,000 - ₹ 25,00,000

    Job SummaryThis is a senior-level position that requires a high level of expertise in regulatory reporting. The successful candidate will have 8+ years of experience in Consulting, Product Management, or Financial Services.A Chartered Accountant or MBA degree is required for this role.Experience with MS Excel and fluency in English language skills are highly...


  • Palakkad, Kerala, India beBeeServicenow Full time ₹ 1,20,00,000 - ₹ 2,00,00,000

    ServiceNow Expert Sought for High-Level PositionLocation: HyderabadFull TimeWe are looking for highly skilled professionals to fill senior-level ServiceNow positions. Key requirements include:A minimum of 10 years of experience with the ServiceNow platform, including expertise in portals (Seismic or Service Portal).Senior-level profiles must have over 10...