Associate Director Global Regulatory Sciences Europe GRS International ICN
Associate Director Global Regulatory Sciences Europe GRS International ICN
Posted on :
03-03-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
03-03-2025
Job Description
Job Title: Associate Director Global Regulatory Sciences Europe GRS International ICN
Job Location: Uxbridge UK
Job Location Type: Hybrid
Job Contract Type: Fulltime
Job Seniority Level: Director
Working with Us
Challenging. Meaningful. Lifechanging. Those aren't 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. You'll 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 .
Responsible for developing and implementing regulatory strategies that maximize the value of our products in the European market. This role requires a deep understanding of European regulatory requirements strategic thinking and the ability to navigate complex regulatory environments to ensure successful product approvals and lifecycle management. This leadership role requires regional accountability with extensive global drug development understanding working in close partnership with the GRL GRT GRS peers including EU countries and the GPT crossfunctional team in line with BMS operating model and governance.
Responsibilities
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/ eeo accessibility 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.
If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information https //careers.bms/californiaresidents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Challenging. Meaningful. Lifechanging. Those aren't 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. You'll 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 .
Responsible for developing and implementing regulatory strategies that maximize the value of our products in the European market. This role requires a deep understanding of European regulatory requirements strategic thinking and the ability to navigate complex regulatory environments to ensure successful product approvals and lifecycle management. This leadership role requires regional accountability with extensive global drug development understanding working in close partnership with the GRL GRT GRS peers including EU countries and the GPT crossfunctional team in line with BMS operating model and governance.
Responsibilities
- Integrates the European regulatory legal scientific/medical and business perspectives to achieve the optimal regulatory outcomes in accordance with company objectives.
- Translates strategy into operational goals and objectives identifies resources and leads to organization to focus on objectives.
- Assures that organization follows through to achieve high quality of plans.
- Contributes and adds value to the writing of scientific documents for regulatory purposes.
- Executes negotiations with EMA in line with BMS strategy and provides strategic directions and supervises negotiations with other relevant regulatory agencies for assigned project.
- Provides direction for maximizing opportunities within projects (e.g. lifecycle) and across the geographical area to support the productivity priorities.
- Participates actively in and represents Global Regulatory Sciences for their project on various multifunctional committees or teams.
- Communicates actively and timely with Global Regulatory Sciences colleagues in European countries including through direction of European Regulatory Teams.
- Active participation in regional organizational activities for the Liaison function (across projects).
- Develops good working relationships with key stakeholders both within and outside the company.
- Builds and maintains good relationships with alliance partners when applicable.
- Watches anticipates and acts on trends and changes in the European and international regulatory environment which may impact the business.
- Scientific/medical background/university scientific degree
- Conducted prior negotiations with (a) regulatory authority(ies)
- Contributed to scientific documents developed for regulatory purposes Established credibility and respect during previous exposure with regulatory authorities and peers
- Demonstrated ability to react appropriately in difficult possibly adverse conditions and/or in crisis situations
- Demonstrated ability to integrate regulatory scientific/medical and business perspectives and to translate this analysis into practical recommendations and operational goals
- Developed working relationships and/or built a team resulting in a performant network or organization
- Understanding of pharmaceutical product development.
- Understanding of EU regulatory principles and their impact on company's development and business
- Understanding of the complexities of cross functional management issues. Understanding of legal and business aspects related to EU regulatory procedures and outcomes.
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/ eeo accessibility 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.
If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information https //careers.bms/californiaresidents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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Employment Type
Full Time
Key Skills
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