Associate Director – Analytics, Global Regulatory Affairs
Takeda
InformaticaPythonTableau
Regulatory Data Steward
Takeda
full-time
Posted on:
Location Type: Remote
Location: Remote • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $137,000 - $215,270 per year
Job Level
Mid-LevelSenior
Tech Stack
CloudSQLTableau
About the role
- Monitor, profile, and analyze regulatory data to ensure compliance with defined standards and design specifications.
- Perform data quality analysis, error detection, documentation, and correction across diverse platforms.
- Investigate, troubleshoot, and document data issues raised by internal and external stakeholders.
- Support root-cause analysis of data issues and recommend process and system improvements.
- Implement data governance policies, standards, and SOPs in partnership with Regulatory Data Owners.
- Define and maintain data quality controls, metrics, and dashboards within data catalogs and reporting tools.
- Identify and escalate regulatory and legal risks related to data issues.
- Act as liaison between Data Owners, Business Process Owners, IT, and external vendors to ensure alignment on remediation and quality improvements.
- Establish, monitor, and report on Service Level Agreements with external vendors.
- Define processes and frequencies for metadata reconciliation and discrepancy resolution.
Requirements
- 5+ years of experience in the healthcare/pharmaceutical industry.
- 5+ years of experience in data management or data governance roles, ideally in a regulatory context.
- Bachelor’s degree in Life Sciences, Pharmacy, Data Science, Information Management, or related field required.
- Master’s degree in Regulatory Affairs, Data Management, or related discipline preferred.
- Strong expertise with the Veeva RIM data model and regulatory metadata management.
- In-depth understanding of regulatory data standards (IDMP, SPOR, XEVMPD, eCTD, etc.).
- Strong analytical and problem-solving skills, including root-cause analysis and remediation.
- Hands-on experience with SQL, Excel, and reporting/visualization tools (Power BI, Tableau, or equivalent).
- Experience working in GxP environments and familiarity with data privacy regulations.
- Ability to work independently with minimal oversight, while influencing diverse stakeholders.
- Excellent communication skills, with the ability to translate technical data concepts into business terms.
- Experience with regulatory domains such as Labeling, CMC, and broader Regulatory Affairs processes.
- Exposure to public and hybrid cloud environments.
Benefits
- U.S. Employees may be eligible for short-term and/or long-term incentives.
- U.S. Employees may be eligible to participate in medical, dental, vision insurance.
- U.S. Employees are eligible to participate in a 401(k) plan and company match.
- U.S. Employees may receive short-term and long-term disability coverage.
- Basic life insurance coverage
- A tuition reimbursement program
- Paid volunteer time off
- Company holidays
- Well-being benefits
- Up to 80 hours of sick time per calendar year
- New hires are eligible to accrue up to 120 hours of paid vacation.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
data managementdata governanceregulatory metadata managementSQLExcelPower BITableauroot-cause analysisdata quality analysiserror detection
Soft skills
analytical skillsproblem-solving skillscommunication skillsinfluencing skillsindependencestakeholder management
