Lead Business Analyst - eCTD 4.0 / CMC & Regulatory Data

Re Focus LLC

Foster City, CA, USA

Published: 6/14/2022

Full Time

Key Responsibilities

eCTD 4.0 Readiness
- Analyze how eCTD 4.0 will impact CMC data structures and processes.
- Define and document new requirements to align with eCTD 4.0 standards.
- Work closely with Regulatory Affairs and CMC teams to ensure submission readiness.
Business Analysis & Process Mapping
- Conduct current state assessment of CMC and Regulatory data systems.
- Identify gaps, risks, and improvement opportunities in current processes.
- Develop future-state process models and functional requirements.
Stakeholder Engagement
- Lead cross-functional workshops with Regulatory, CMC, IT, and Data Governance teams.
- Translate complex regulatory requirements into actionable system and data requirements.
- Communicate project updates to stakeholders and leadership.
System Evaluation & Implementation Support
- Evaluate and recommend system changes or enhancements required to support eCTD 4.0.
- Partner with technical teams for solution design and validation.
- Support UAT (User Acceptance Testing) and training for impacted users.
Leadership
- Lead and mentor a small team of Business Analysts working on regulatory data initiatives.
- Act as a Business Analyst lead for eCTD 4.0 and CMC data readiness streams.

Qualifications

7+ years of Business Analyst experience in Pharmaceutical or Biotech industry.
Proven experience with Regulatory Affairs and CMC processes.
In-depth understanding of eCTD submission process (eCTD 3.2.2 and 4.0 preferred).
Strong experience in Regulatory Information Management (RIM) and Document Management Systems (DMS).
Familiarity with CMC data management and structured content authoring is a plus.
Experience leading cross-functional teams and Business Analysts.
Excellent communication, facilitation, and stakeholder management skills.

Preferred Tools / Knowledge