Key Responsibilities
Regulatory & Business Leadership
- Act as the primary functional partner for Regulatory Affairs, Pharmacovigilance, and Compliance stakeholders.
- Lead analysis of regulatory processes and data domains including submissions, product, labelling, safety, manufacturing, and compliance data.
- Translate regulatory and compliance needs into clear functional, data, and reporting requirements.
Requirements Management & BA Ownership
- Lead end-to-end requirements lifecycle including elicitation, analysis, documentation, review, approval, and sign-off.
- Define and manage epics, features, and user stories with clear acceptance criteria.
- Maintain traceability between business requirements, data transformations, and BI reports.
- Facilitate requirement walkthroughs, impact analysis, and change management.
Snowflake, Ingestion & dbt Transformation Oversight
- Lead business requirements for Snowflake migration and data ingestion initiatives.
- Own source-to-target mappings, business rules, and data quality requirements implemented via dbt models.
- Partner with data engineering teams to review dbt transformations, testing approaches, and documentation.
Data Quality, Validation & UAT
- Define data validation, reconciliation, and acceptance criteria for regulatory datasets.
- Lead UAT planning, execution, defect triage, and business sign-off in collaboration with development and QA teams.
- Ensure regulatory accuracy, audit readiness, and end-to-end data lineage.
Agile Delivery & Collaboration
- Actively participate in Agile ceremonies including backlog grooming, sprint planning, daily stand-ups, reviews, and retrospectives.
- Manage and track work items using Jira; maintain BA artifacts and documentation in Confluence.
- Collaborate closely with data engineers, platform administrators, QA, and BI teams to ensure timely and quality delivery.
- Mentor junior BAs and provide functional leadership across workstreams.
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Required Skills & Qualifications
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, IT, or related field.
- 8+ years of Business Analyst experience in Life Sciences, with strong Regulatory domain focus.
- Proven experience on Snowflake migration, ingestion, and analytics programs.
- Expertise in epics, user stories, acceptance criteria, UAT, and Agile delivery practices.
- Proficiency with Jira, Confluence, and enterprise requirement management tools.
- Strong stakeholder management, communication, and documentation skills.
