Associate Director, Global Regulatory Sciences Europe, Grs International Icn

**Working with Us**
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.

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 cross-functional 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 execution 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. life-cycle) 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.

**Requirements**:

- 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, Life-changing Careers**

**On-site Protocol**

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 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