Regulatory Affairs Specialist

1 day ago

Noida, Uttar Pradesh, India beBeeProduct Full time ₹ 15,00,000 - ₹ 20,00,000

We are seeking a skilled technical professional to fill this role. The ideal candidate will possess:

  • Strong knowledge of pharmaceutical regulatory frameworks and data integrity standards.
  • Excellent communication and interpersonal skills, with ability to facilitate workshops and collaborate with cross-functional teams.
  • Proven experience in managing product backlogs and ensuring delivery of complex projects.
  • Knowledge of JIRA, Confluence, and other digital tools used in the industry.
About the Job

This is a challenging opportunity for an experienced professional looking to grow their career in the field of regulatory affairs. As a technical product specialist, you will be responsible for acting as a technical product owner for global regulatory systems and solutions, ensuring alignment with business goals and compliance requirements.

The key responsibilities include gathering, analyzing, and documenting business requirements from regulatory stakeholders across global regions, ensuring clarity and completeness. You will also be responsible for managing product backlogs in JIRA, defining clear user stories, acceptance criteria, and prioritization based on business value.

Key Responsibilities
  1. Acting as a technical product owner for global regulatory systems and solutions, ensuring alignment with business goals and compliance requirements.
  2. Gathering, analyzing, and documenting business requirements from regulatory stakeholders across global regions, ensuring clarity and completeness.
  3. Managing product backlogs in JIRA, defining clear user stories, acceptance criteria, and prioritization based on business value.
  4. Collaborating with development, QA, and regulatory teams to ensure product features meet both technical specifications and regulatory standards.
  5. Facilitating workshops, requirement-gathering sessions, and backlog grooming using Confluence for documentation and collaboration.
  6. Driving solution design discussions, ensuring integration with existing regulatory and submission management platforms.
  7. Overseeing end-to-end delivery of regulatory systems enhancements, including planning, testing, validation, and deployment.
  8. Ensuring adherence to pharmaceutical regulatory frameworks (e.g., FDA, EMA, ICH) and compliance with data integrity and GxP standards.
  9. Partnering with IT, quality, and compliance teams to manage change control and validation activities for regulated systems.
  10. Providing thought leadership on digital tools and process optimization in the global regulatory affairs space.
  11. Supporting User Acceptance Testing (UAT) by developing test scenarios, coordinating execution with business users, and validating results against requirements.
  12. Tracking, triaging, and resolving defects identified during UAT, working closely with developers and testers to ensure timely fixes.
  13. Participating in and leading daily Scrum stand-ups, sprint planning, reviews, and retrospectives to ensure team alignment and delivery velocity.
Requirements

The ideal candidate will possess:

  • Strong understanding of pharmaceutical regulatory frameworks and data integrity standards.
  • Excellent communication and interpersonal skills, with ability to facilitate workshops and collaborate with cross-functional teams.
  • Proven experience in managing product backlogs and ensuring delivery of complex projects.
  • Knowledge of JIRA, Confluence, and other digital tools used in the industry.
  • Ability to analyze business requirements and develop clear user stories and acceptance criteria.

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