Regulatory Data Lead
Pfizer
full-time
Posted on:
Location Type: Hybrid
Location: Groton • Connecticut, New York, Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $169,700 - $282,900 per year
Job Level
Senior
Tech Stack
Vault
About the role
- Maintains overall accountability for the accuracy and compliance of product master and event data.
- Oversight and management of people, technical resources and budget associated with TA aligned Regulatory Data Vanguard.
- Foster strong working relationships with GRS and CMC LT leaders.
- Lead Team delivering end to end data management and process execution.
- Demonstrate comprehensive knowledge of the Regulatory Continuum and Vault RIM functionality.
- Play a leading role in the continued harmonisation of data standards.
- Ensure all in scope activities are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.
Requirements
- Bachelor’s or Master’s degree, preferably in Life Sciences, Regulatory Affairs, Data Management, or related field.
- 8+ years of experience in Regulatory Affairs or Regulatory Operations, with at least 2 years in a data governance, data management, or data quality/compliance role.
- 3+ years management & supervisory experience in a regulatory field managing global and/or local resources & resource capacity algorithms.
- Fluent in English.
- Robust understanding of biopharmaceutical industry, regulatory and safety processes, external/internal environment.
- Detailed understanding of regulatory system structures.
Benefits
- Health benefits to include medical, prescription drug, dental and vision coverage.
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation, holiday and personal days
- Paid caregiver/parental and medical leave
- Eligibility to participate in Pfizer’s Global Performance Plan with a bonus target of 20.0% of base salary.
- Participation in share based long term incentive program
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
data managementdata governancedata qualityregulatory complianceregulatory affairsregulatory operationsdata standardsresource capacity algorithmsVault RIM functionalityregulatory system structures
Soft skills
leadershiprelationship buildingteam managementaccountabilitycommunication
Certifications
Bachelor’s degreeMaster’s degree