Bristol Myers Squibb Director - Global Regulatory Europe in Uxbridge, United Kingdom
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
We are currently recruiting for a Director - Global Regulatory Science-Europe (Immunoscience, fibrosis, Cardiovascular, and Neuroscience therapeutic areas)
Supervision of ERLs (European Regulatorily leads) responsible for assigned therapeutic areas. This covers the following activities:
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 purpose
Executes negotiations with EMA in line with BMS strategy, 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 strong working relationships with key stakeholders both within and outside the company
Builds and maintains strong relationships with alliance partners when applicable
University degree in life sciences (PhD, PharmD, Msc, others) required
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, behaviours, professional standards and cultural sensitivity compatible with BMS vision and culture.
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
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognises 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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. If you require reasonable adjustments in completing this application, or any part of the recruitment process direct your enquiries to email@example.com. Applicants can request an approval of an adjustment prior to accepting a job offer.
Company: Bristol Myers Squibb
Req Number: R1539042
Updated: 2021-06-22 04:46:17.234 UTC
Location: Uxbridge,United Kingdom
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.