Job Description

Associate Director, Global Regulatory Sciences Liaison, Oncology - Europe (id 1805)

- Pharmaceuticals
Posted by Luc Decat on 30/09/2020

Expected Areas of Competence:

    • 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. life-cycle) and across the geographical area to support the productivity priorities.
    • Participates actively in and represents ORS-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.

Integrity

We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues.

Innovation

We pursue disruptive and bold solutions for patients Core

Urgency

We move together with speed and quality because patients are waiting

Passion

Our dedication to learning and excellence helps us to deliver exceptional results

Accountability

We all own company's success and strive to be transparent and deliver on our commitments

Inclusion

We embrace diversity and foster an environment where we can all work together at our full potential.

 

 

 

Experiences Desired:

    • 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 com

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.
    • Compatible with BMS vision and culture.

Developmental value:

    • Optimal position to learn and understand the perspectives of key stakeholders (both internal: R&D, Marketing, Legal, etc...and external: regulatory and public health authorities, scientific community).
    • Gain increased understanding of company strategies, decision processes and implementation processes.
    • Learn to leverage personal impact by addressing complexity, setting priorities, translating strategies into operational goals and objectives, and exerting leadership to enhance organizational performance

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