# Regulatory Affairs

**Company**: Pfizer
**Location**: New York City, New York
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Salary**: $124,400.00 to $207,400.00
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/United-States---New-York---New-York-City/Regulatory-Data-Excellence---Integrity-Lead_4965995-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_a561858f-486

## Description

We are seeking a Regulatory Affairs professional to oversee and execute global data management activities in support of new and remediation activities. The successful candidate will be accountable for the overall integrity and quality of Pfizer Global regulatory data through the oversight of data quality, completeness, and timeliness.

Responsibilities include:

- Overseeing global data management activities and stewardship of Regulatory Milestones and license status conformance within regulatory systems

- Championing innovation and taking calculated risks to challenge the status quo, resulting in enhanced processes that impact business directions of cross-functional teams and Business Units

- Influencing senior management decisions that have an impact on business direction to support global regulatory data strategies across all global business units and markets

- Leading the evolution of data management & quality oversight in partnership with business and digital partners

- Ensuring overall data integrity through audit and verification checks, performing quality control of timeliness, accuracy, and completeness of data

- Developing key performance indicators to ensure accurate and timely execution of improvement initiatives and guarantee increased compliance in relevant processes

- Liaising with business process owners, ensuring interpretations of compliance requirements and providing input

- Establishing effective and open communication with all relevant stakeholders to ensure appropriate staffing and coverage

- Coaching, mentoring, and developing staff, including overseeing new employee onboarding and providing career development planning and opportunities

Requirements:

- Bachelor's degree with 6 or more years or a Master's degree with 4 or more years in Life Sciences, Regulatory Affairs, Data Management, or related field

- Strong experience in Regulatory Affairs or Regulatory Operations and data governance, data management, or data quality role

- Proven experience managing colleagues and/or contractors within a matrix environment

- Robust understanding of biopharmaceutical industry, regulatory and safety processes, external/internal environment

- 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 and support compliance

- Computer literacy in Microsoft 365/Teams/Adobe Acrobat

- Experience with publishing software, XML, Document Management, regulatory milestone reporting tools

- Ability to embrace innovative technologies and process and drive implementation remotely

- Articulate with strong analytical and interpersonal skills

- Strong Project Management Skills

- Experience with master data management and data quality improvement

- Technical Expertise: Demonstrated knowledge of / experience with strategic business planning and operations

- Communications Skills: Ability to communicate complex information and analyses, and difficult messages, to a variety of audiences in both verbal and written format

- Business Perspective: Cross-functional, Global perspective within the context of business needs and impact

- Proven ability to influence and lead cross-functional teams without direct authority

Benefits:

- Comprehensive and generous benefits and programs to help colleagues lead healthy lives and support each of life's moments

- 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution

- Paid vacation, holiday, and personal days

- Paid caregiver/parental and medical leave

- Health benefits, including medical, prescription drug, dental, and vision coverage

## Skills

### Required
- Life Sciences
- Regulatory Affairs
- Data Management
- Microsoft 365
- Project Management
- Data Quality
- Regulatory Compliance

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Source: [Apply at pfizer.wd1.myworkdayjobs.com](https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/United-States---New-York---New-York-City/Regulatory-Data-Excellence---Integrity-Lead_4965995-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)