Senior Regulatory Data Engineer

3 days ago

Hyderabad Secunderabad Telangana, India beBeeRegulatoryDataEngineering Full time ₹ 1,04,000 - ₹ 1,30,878
Regulatory Data Engineering Leadership Role

We are seeking a seasoned professional to lead our end-to-end data strategy and execution for regulatory product submissions, lifecycle management, and compliance reporting. This role will drive integration between scientific, regulatory, and engineering functions to support submission-ready data and regulatory intelligence solutions.

This is an opportunity to leverage your expertise in data engineering and regulatory compliance to drive innovation and growth in the biotech and pharmaceutical industry. As a senior leader, you will be responsible for managing a team of data engineers and analysts, fostering a culture of excellence, innovation, and delivery.

The ideal candidate will have a strong background in data engineering, regulatory affairs, and project management. They will be able to translate technical capabilities into regulatory and business outcomes, ensuring timely and accurate delivery of regulatory data assets across global markets.

Key Responsibilities:
  • Develop and implement end-to-end data strategies for regulatory operations, including data ingestion, transformation, integration, and delivery.
  • Serve as the data engineering SME in the Integrated Product Team (IPT) to support regulatory submissions, agency interactions, and lifecycle updates.
  • Collaborate with global regulatory affairs, clinical, CMC, quality, safety, and IT teams to gather submission data requirements and translate them into data engineering solutions.
  • Manage and oversee the development of data pipelines, data models, and metadata frameworks that support submission data standards (e.g., eCTD, IDMP, SPL, xEVMPD).
  • Enable integration and reporting across regulatory information management systems (RIMS), EDMS, clinical trial systems, and lab data platforms.
Requirements:
  • 8-12 years of experience in data engineering or data architecture, with 3+ years in a senior or managerial capacity.
  • Proven experience supporting regulatory functions, including submissions, tracking, and reporting for FDA, EMA, and other global authorities.
  • Experience with ETL/ELT tools, data pipelines, and cloud-based data platforms (e.g., Databricks, AWS, Azure, or GCP).
  • Familiarity with regulatory standards and data models such as eCTD, IDMP, HL7, CDISC, and xEVMPD.
  • Deep understanding of GxP data compliance, audit requirements, and regulatory submission processes.
Preferred Qualifications:
  • Prior experience working on integrated product teams or regulatory transformation programs.
  • Knowledge of Regulatory Information Management Systems (RIMS), Veeva Vault RIM, or Master Data Management (MDM) in regulated environments.
Education and Professional Certifications:
  • 12 to 15 years of experience in Computer Science, IT or related field
  • Scaled Agile SAFe certification preferred
  • Project Management certifications preferred
Soft Skills:
  • Excellent analytical and troubleshooting skills
  • Strong verbal and written communication skills
  • Ability to work effectively with global, virtual teams
  • High degree of initiative and self-motivation

  • Senior Data Engineer

    2 weeks ago

    Hyderabad / Secunderabad, Telangana, India beBeeDataEngineering Full time

    Data Engineering Manager RoleWe are seeking a seasoned Data Engineering Manager to lead our end-to-end data strategy and execution for regulatory product submissions, lifecycle management, and compliance reporting.This role will be embedded in a cross-functional Regulatory Integrated Product Team (IPT) and serve as the data and technology lead, driving...

  • Senior Regulatory Systems Leader

    1 week ago

    Hyderabad / Secunderabad, Telangana, India beBeeRegulatory Full time ₹ 1,04,000 - ₹ 1,30,878

    Are you a strategic leader seeking a new challenge?As a Senior Manager of Regulatory Data Management, you will play a pivotal role in shaping and implementing our system-based framework. This senior position involves building and leading a high-performing team focused on delivering global regulatory data management services within the regulatory information...

  • Senior Regulatory Compliance Specialist

    1 week ago

    Hyderabad / Secunderabad, Telangana, India beBeeRegulatoryAffairs Full time ₹ 1,04,000 - ₹ 1,30,878

    Job Title: Regulatory Affairs Senior AssociateOur company seeks an experienced Regulatory Affairs Senior Associate to join our team. The ideal candidate will have a strong background in regulatory affairs and be able to work effectively with cross-functional teams."],

  • Senior Software Engineer

    2 weeks ago

    Hyderabad / Secunderabad, Telangana, India beBeeSoftware Full time

    Job Description:As a senior associate software engineer, you will be responsible for delivering innovative custom solutions to support patient safety and regulatory compliance. You will work closely with the team to advance technical features and enhancements of business applications, incorporating machine learning and natural language processing...

  • Senior Data Engineer

    2 weeks ago

    Hyderabad / Secunderabad, Telangana, India beBeeData Full time

    Job Title: Senior Data EngineerKey Responsibilities:We are seeking a highly skilled and experienced Senior Data Engineer to lead the design, development, and implementation of large-scale data pipelines using Python, Pyspark, and SQL. The ideal candidate will have strong technical expertise in data engineering concepts, with the ability to handle multiple...

  • Senior Data Engineer

    1 week ago

    Hyderabad / Secunderabad, Telangana, India beBeeData Full time ₹ 1,04,000 - ₹ 1,30,878

    About the RoleThis is a senior data engineering position focused on utilizing business acumen to work with stakeholders and other data engineers to define, design, and implement data solutions that support the organization s data initiatives. The ideal candidate will have experience in designing and building pipelines using cloud technology for extracting,...

  • Senior Data Infrastructure Engineer

    7 days ago

    Hyderabad / Secunderabad, Telangana, India beBeeDataInfrastructure Full time ₹ 1,04,000 - ₹ 1,30,878

    Senior Data Infrastructure EngineerWe are seeking a highly skilled and experienced Senior Data Infrastructure Engineer to join our team. As a key member of our data engineering organization, you will play a critical role in designing, building, and maintaining scalable data pipelines that support our analytics and reporting needs.

  • Regulatory Operations Specialist

    2 weeks ago

    Hyderabad / Secunderabad, Telangana, India beBeeDataManagement Full time

    Job DescriptionThe Senior Associate, Data Management role involves spearheading key business operation initiatives within Veeva RIM Vault. This ensures alignment with global regulatory requirements, such as IDMP, EU CTR, and other emerging regulations.As a subject matter expert in Veeva RIM Vault, you will collaborate with cross-functional teams to drive...

  • Senior Regulatory Intelligence Professional

    1 week ago

    Hyderabad / Secunderabad, Telangana, India beBeeRegulatory Full time ₹ 1,04,000 - ₹ 1,30,878

    Job Title:Regulatory Intelligence Senior ManagerKey Responsibilities:(1) Contribute to the monitoring, analysis, and reporting of global regulatory developments to support timely and compliant product submissions.(2) Deliver high-quality regulatory intelligence outputs such as summaries of country-specific requirements, impact assessments, and...

  • Regulatory Data

    2 weeks ago

    Hyderabad, Telangana, India Amgen Full time

    Roles & Responsibilities: - Data Administration/AI: Optimize and maintain the organization's complex data models, ensuring they are integrated, efficient, and compliant with regulatory requirements. - Regulatory Business Analysis: Interpret and implement regulatory requirements, ensuring all systems and processes adhere to relevant regulatory requirements...