Medical and Regulatory Affairs
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.
Position Summary / Objective
This will be an evolving role supporting the business in evaluation of capabilities and business processes necessary across the enterprise in order to meet upcoming global regulatory requirements for submission of IDMP (Identification of Medicinal Products) data based on local implementation guides. This includes preparing for the first implementation project, from tool selection to data readiness and everything in between. The role needs to take into account both the internal and external environment and requirements, and serves as the BMS process and requirements expert for the future capability (IDMP).
The role will serve as a lead on one of the areas of data remediation and/or the business implementation workstream. The role will also assist in data quality/compliance activities. After EMA IDMP go live, this role will transition into management of the IDMP operations activities.
Maintains expert level knowledge of the assigned Regulatory Capabilities and/or Processes
Manages the development of business plans to optimize assigned regulatory capabilities and/or processes
Manages process implementations and/or system enhancements in developed areas of expertise
Provides support for internal audits, HA inspections and corrective preventive action plans, and is responsible for resolution of identified actions in developed areas of expertise
Supports governance boards meeting preparation and participates in resulting initiatives for assigned regulatory capabilities and /or processes
Manages and executes daily stewardship activities and proactively identifies compliance issues for assigned processes
Manages and executes operational aspects of assigned regulatory systems and/or processes to ensure compliance
Minimum of a BS/BA in a relevant scientific or technical field
Minimum of 3 years work in Regulatory Affairs or minimum of 5 years of pharmaceutical industry experience
Experience with IDMP preferred
Key Competency Requirements
Demonstrates strategic thinking skills, and has the ability to drive projects/workstreams based on group/company objectives
Demonstrates understanding of the procedures and decision-making process of relevant Health Authorities.
Strong understanding and knowledge of regulatory operations
Knowledge and experience with computer systems in an R&D environment
Understanding of system validation / testing, and electronic records regulations
Experience in leading small projects, some management of people in a matrix as well as dealing with external customers and contractors
Solid understanding of desktop application software suites
Good command of the English language, and able to communicate in both written and oral forms. Strong presentation skills.
Some travel may be required once or twice a year
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.