We redefine Regulatory Excellence. What about you?
There has never been a more interesting time to work at Regulatory Excellence. We are on a journey that is centered around our patients, powered by technology and driven by smart, determined people.
Our internal customers feel our people are empowering them to stay one-step ahead in processes and in business.
Would you like to work for an area where innovation, integrity and responsibility are valued? Are seeking proactively opportunities to learn, thinking ahead and caring for others part of your skills?
Do you want to make the difference for our internal customers thanks to our agile way of working?
If the answer is yes , the Regulatory Excellence role is waiting for you. This role is designed to coordinate the implementation of cross-
functional processes, build metrics and support data analysis to make assertive decisions, and contribute with the adoption of Regulatory Intelligence for the region.
Your Key Responsibilities
Support the simplification and optimization of the Chemistry Manufacturing and Control (CMC) process
Monitor the Labeling process assuring activities are performed in compliance with guiding principles and local regulations
Work in partnership with Local Affiliates, Labeling Operations, Supply and Quality Assurance regarding implementation of labeling changes and time frame for Final Distribution Date.
Work with management to provide advice on and ensure that changes in labeling are reflected in current promotional materials in compliance with guiding principles and local regulations
Train regulatory colleagues and stakeholders on regulatory local working instructions
Look for opportunities to optimize local processes, revise and maintain local working instructions
Build process metrics and support data analysis to make assertive decisions
Support the development and update of a Regulatory Intelligence matrix that generates a meaningful output to the regulatory strategy
Collaborate and build relationships with internal and external stakeholders, including Commercial, Medical, Legal and Compliance
We look for
A colleague who is passionate about processes and eager to challenges the status quo. Besides strong analytical skills, have the capacity to translate complexity into easy language.
Strong social and coordination skills are key in supporting colleagues and stakeholders with the interpretation and useful usage of regulatory information and the coordination of areas to develop the regulatory intelligence matrix.
A colleague with talent for take it on and make it happen , enthusiasm for helping others to be successful and knack for always being a step ahead.
You will also need to
Have excellent verbal and written communication skills
Have ability to communicate effectively with cross functional teams
Have analytical and planning skills
Be capable to build trusted relationships with stakeholders
Be able to embrace challenges in a quickly changing, complex and uncertain environment
Be pro-active and pragmatic, looking for easy solutions
Be able to analyze and extract relevant and precise information from large quantities of information
University degree (Health Care Professional preferable)
Experience of minimum 2 years in the pharmaceutical industry
Knowledge of the BMS Portfolio
Good understanding of BMS Regulatory processes and Health Authority regulations
Demonstrated flexibility to work simultaneously on multiple projects in an organized and consistent manner, even under constrained timelines
Excellent English written and oral skills
Management of Microsoft Office and other technology tools as SharePoint