Associate Director EU Regulatory Strategy Lead - Oncology and Hematology
Bristol-Myers Squibb Company, Uxbridge, Greater London
Associate Director EU Regulatory Strategy Lead - Oncology and Hematology
Salary Not Specified
Bristol-Myers Squibb Company, Uxbridge, Greater London
- Full time
- Permanent
- Onsite working
Posted today, 5 Oct | Get your application in now to be one of the first to apply.
Closing date: Closing date not specified
job Ref: 549d71597838413fb8e0b393afe65c69
Full Job Description
- Integrates the European regulatory, legal, scientific/medical and business perspectives to achieve the optimal regulatory outcomes for assigned project(s) in accordance with company objectives.
- Translates strategy into operational goals and objectives, identifies resources and leads the organization to focus on objectives. Assures that organization follows through to achieve high quality execution of plans.
- Ability to contribute and add value to the writing of scientific documents for regulatory purpose.
- Able to act as Contact Person for assigned project(s) with EMA in line with BMS strategy and to provide strategic directions and supervise negotiations with other relevant regulatory agencies for assigned project.
- Provides direction for maximizing opportunities within projects (eg. lifecycle) and across the geographical area to support the productivity priorities.
- Participates actively in and represents GRS-EU for their project(s) in the Global Regulatory Team and on various multi-functional 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 strong working relationships with key stakeholders both within and outside the company.
- Builds and maintains strong relationships with alliance partner when applicable.
- Watches, anticipates and acts on trends and changes in the European and international regulatory environment which may impact on the business., BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design 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 field-based and remote-by-design 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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
- Conducted prior negotiations with (a) regulatory authority(ies)
- Contributed to scientific documents developed for regulatory purpose.
- 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 build a team resulting in a performant network or organization
- Demonstrated values, behaviors, professional standards and cultural sensitivity compatible with BMS vision and culture. Knowledge Desired:
- Strong scientific/medical background.
- Understanding of pharmaceutical product development
- Understanding of European 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 European regulatory procedures and outcomes.
Challenging. Meaningful. Life-changing. 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 high-achieving 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.com/working-with-us .