Regulatory Compliance Specialist

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Division

Research and Development / Global Regulatory, Safety and Biometrics / Global Submissions Regulatory Policy - Global Regulatory Business Capabilities

Functional Area Description

Global Regulatory Business Capabilities

In collaboration with the business, sets the strategic business direction for the development and maintenance of systems used in GRS, including responding to any needs for regulatory data from other parts of the BMS enterprise

Oversees strategic direction of the data quality programs necessary to achieve and maintain high data quality in GRS systems

Oversees and leads the development, data readiness, process development and country onboarding of BMS’ medical product data management program Establishes and maintains a set of regulatory standards for data and processes in scope

Responsible for the leadership and oversight of operational activities for implemented systems and processes

Evaluates internal and external requirements and guidances with impact to BMS compliance and processes, especially where systems are impacted

Position Summary / Objective

The Regulatory Compliance Specialist is responsible for the following:

Running and analyzing reports in the Verity system or other regulatory information systems

Contacting and guiding functional area colleagues and work groups in order to correct any findings

Preparing metrics, trend analysis, and compliance readout presentations

Determining which checks will be done in any given quarter

Working with subject matter experts to create/refine requirements and/or escalation points

Training new resources in compliance processes and systems

Position Responsibilities

Maintains comprehensive knowledge of the assigned regulatory processes with multiple areas of expertise

Supports and participates in the development of process optimization, manages daily workload and serves as a process expert assigned processes

Contributes to process implementations and/or system enhancements in developed areas of expertise

Provides support for internal audits, HA inspections and participates in the resolution of corrective preventive action plans in defined area of expertise

At the request of management, prepares data in support of governance meetings, and contributes to resulting initiatives in developed areas of expertise

Executes daily data stewardship activities and is able to identify compliance issues for assigned processes

Executes operational aspects of assigned regulatory processes to ensure compliance

Degree Requirements

BS/BA in a relevant scientific or technical field preferred. Additional experience may be considered in lieu of a degree

Experience Requirements

Minimum of 2 years work in Regulatory Affairsor

Minimum of 3 years of pharmaceutical industry experience

Key Competency Requirements

Applies critical thinking skills to daily workload decisions, in alignment with group/company objectives

Demonstrates some understanding of the procedures and decision-making process of relevant Health Authorities.

Strong understanding and practical knowledge of regulatory operations

Knowledge and some experience with computer systems in an R&D environment

Understanding of electronic records management rules

Contributes to projects and understands how to communicate and interact with internal and external customers

Good understanding of standard desktop application software suites with proficiency in Excel and Outlook especially.

Proficient in the English language both written and oral, and able to communicate effectively in written form with non-English speakers. Good presentation skills

Travel Required

None

Describe Exposure to Any Hazards/Disagreeable Conditions in the Work Environment

Not Applicable

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com