Senior Regulatory Manager -ERPS
Senior Regulatory Manager -ERPS
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1 Vacancy
Job Description
Working with Us
Challenging. Meaningful. Lifechanging. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside highachieving teams rich in diversity. Take your career farther than you thought possible.
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 with the resources to pursue their goals both at work and in their personal lives. Read more: careers.bms/workingwithus
Position Purpose
The European Regulatory Procedural Strategist (ERPS) team leads and manages the procedural and operational aspects of the European regulatory filings within the European Centralised Procedure working in close collaboration with the European Regulatory Liaison group and the appropriate regional and global functions.
Key Responsibilities
Manages the operational and procedural aspects and provide support for new Marketing Authorisation Applications preparation and filings and also Life Cycle Management for the European Centralised Procedures
Plan and track activities related to regulatory submissions in the EU.
Systematic communicator of regulatory submission dates regulatory status nature of changes track and inform of minor/significant product information changes to all relevant parties.
Provide logistic support for meetings with EMA and national Health Authorities and any other related meetings in connection to the assigned project.
Working together with the European Regulatory Liaison (ERL) in the development process of European strategy through research (competitors guidelines... and membership of multidisciplinary Project Teams (including with business)
Author regulatory documentation in Module 1 and lead review of quality variations.
Backup ERL as needed in teams and with Health Authorities.
Lead reviews of new legislations and guidelines as appropriate and author/review internal procedures and processes. Represent the group in interdepartmental (global) taskforces.
Develop and ensure maintenance planning tracking/monitoring of processes.
Keep abreast of regulatory requirements and changes competitive activities changes in Governmental authorities and requirements to enhance the effectiveness of the function.
Qualifications and Experience
Solid scientific background (PhD level desired).
Demonstrated (hands on) experience of direct (or relevant) in European regulatory procedures or (in)direct management experience of major projects
leadership skills.
Key competencies
Work on LCM and MAA with minimum supervision support early projects take leadership role for nonproject based support. Take initiative to support and serve as backup for other ERPS
Represent the department in Global task forces develop processes inter and intra dept.
Take part of the training and integration of new members.
Great communication organisation and attentiontodetail skills as well as in depth knowledge of EU Regulatory requirements are clear specificities and a must for the job.
Good interpersonal skills strong team spirit and ability to connect and collaborate are found essential for this particular job due to the high team collaboration and practice harmonisation expected from this group as well as to the extent of the crossfunctional interactions involved in the daily work.
Excellent command of spoken and written English.
Ability to rapidly adapt to different issues and projects at one time.
Good understanding of the pharmaceutical industry and have an understanding of European Regulatory Procedures.
#LIHybrid
If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work Lifechanging Careers
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture promoting diversity in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.
Onsite Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes siteessential sitebydesign fieldbased and remotebydesign jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Siteessential roles require 100 of shifts onsite at your assigned facility. Sitebydesign roles may be eligible for a hybrid work model with at least 50 onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For fieldbased and remotebydesign roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application or in any part of the recruitment process direct your inquiries to . Visit careers.bms/eeoaccessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your wellbeing and the wellbeing of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid19 and keep up to date with Covid19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Bristol Myers Squibb is Disability Confident Employer
A UK Government scheme
Required Experience:
Manager
Employment Type
Full-Time
