Global Regulatory Systems Specialist

22 hours ago

Noida, Uttar Pradesh, India beBeeRegulatory Full time ₹ 40,00,000 - ₹ 45,00,000
**Regulatory Affairs Expert**: We are seeking a highly skilled Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong understanding of regulatory frameworks and guidelines, as well as excellent communication and project management skills.
This is an exciting opportunity to work with our global regulatory systems and solutions, ensuring alignment with business goals and compliance requirements. You will be responsible for gathering, analyzing, and documenting business requirements from regulatory stakeholders across global regions.
You will manage product backlogs in JIRA, defining clear user stories, acceptance criteria, and prioritization based on business value. Collaboration with development, QA, and regulatory teams is essential to ensure product features meet both technical specifications and regulatory standards.
We require candidates with excellent analytical and problem-solving skills, as well as the ability to work effectively in a fast-paced environment. Experience with digital tools and process optimization in the global regulatory affairs space is highly desirable.
In this role, you will oversee end-to-end delivery of regulatory systems enhancements, including planning, testing, validation, and deployment. Ensure adherence to pharmaceutical regulatory frameworks (e.g., FDA, EMA, ICH) and compliance with data integrity and GxP standards.
Key responsibilities include managing change control and validation activities for regulated systems, partnering with IT, quality, and compliance teams to ensure seamless integration. Provide thought leadership on digital tools and process optimization in the global regulatory affairs space.
Requirements:
  • Gather, analyze, and document business requirements from regulatory stakeholders across global regions
  • Manage product backlogs in JIRA, defining clear user stories, acceptance criteria, and prioritization based on business value
  • Collaborate with development, QA, and regulatory teams to ensure product features meet both technical specifications and regulatory standards
  • Oversee end-to-end delivery of regulatory systems enhancements, including planning, testing, validation, and deployment
  • Ensure adherence to pharmaceutical regulatory frameworks (e.g., FDA, EMA, ICH) and compliance with data integrity and GxP standards

About Us:

We are a dynamic organization dedicated to driving societal progress by enabling our customers to run businesses with unmatched efficiency and innovation. Our core values prioritize Diversity, Equity, and Inclusion (DEI) initiatives, along with Corporate Sustainable Responsibility (CSR) activities.

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