- Lead the accurate definition & recording of master data in alignment with data standards.
- Execute & oversee application/registration creation in collaboration with GRS.
- Ensure data consistency and accuracy across different systems and platforms.
- Conduct regular QC, data audits, identify data issues, and adhere to data quality standards.
Requirements
- Bachelor's degree with at least 5+ years of experience; OR a master's degree with at least 3+ years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8+ years of experience; OR a high school diploma (or equivalent) and 10+ years of relevant experience.
- Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Data Management, or related field.
- 4+ years of experience in Regulatory Affairs or Regulatory Operations, with at least 3+ years in a data governance, data management, or data quality role.
- Strong understanding of global regulatory submission and compliance requirements.
- Detailed understanding of regulatory system structures and how they are intended to enable regulatory business needs (e.g., Veeva RIM, Liquent, Lorenz).
- Strong understanding of data governance principles and best practices, certification in data management or data governance (e.g., ISO IDMP, xEVMPD, SPL).
- Must be fluent in English.
Core Competencies
Demonstrates expertise in data governance, data management, and regulatory compliance, ensuring data accuracy and consistency across systems. Proficient in regulatory submission processes and familiar with industry-specific tools and standards.
Highest-signal resume keywords
- Data Governance
- Regulatory Affairs
- Data Quality Management
- Regulatory Compliance
- Data Management
ATS Optimization Keywords
Hard Skills
- Data Audits
- Data Standards
- Data Consistency
- Data Accuracy
- Master Data Definition
Certifications & Qualifications
Industry Keywords
- Life Sciences
- Regulatory Operations
- Global Regulatory Submission
- Data Governance Principles
Tools & Technologies