Regulatory Strategic Partnership Lead

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Date: Apr 6, 2019

Location: Warsaw, Warsaw, PL

Regulatory Strategic Partnership Lead - Region

Global Regulatory Affairs  

 

Help us transform patients’ lives.

 

At UCB, we put our heart, soul and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?

To strengthen our Global Regulatory Strategic Partnership team, based in our headquarter in Brussels, BE, we are looking to fill the position of:

Regulatory Strategic Partnership Lead - Region.

 

Are you analytical with innovative capacities? At UCB that makes you an ‘analyvative’ person. This unique blend of talent means you are good at processing facts to forge new solutions for patients.

As a UCB 'analyvative' person and Regulatory Strategic Partnership Lead - Region you like to work in an environment where you can:

 

  • Act as Regulatory Strategic Partnership Lead to interface between broader UCB global and local stakeholder community and the local Regulatory Strategic Partner for the assigned region. Build and maintain a strong, mutual and effective relationship, fostering transparency, trust and collaboration with all Stakeholders.
  • Provide effective management and oversight of Regulatory Strategic Partner through deployment of/ utilization of specific portfolio management tools/systems to plan, monitor and report upon regulatory activities and related budget.
  • Ensure with Regulatory Strategic Partner efficient oversight of on/off boarding, training and training compliance of staff.
  • Provide global regulatory strategic and operational expertise in close collaboration with Global Regulatory Lead, to relevant key internal stakeholders (Business units, affiliates) and external partner(s) to ensure qualitative and timely execution of product regulatory plans through the Regulatory Strategic Partner in support of business and compliance needs

 

As a UCB 'analyvative' person and Regulatory Strategic Partnership Lead - Region you will contribute by:

 

  • Leading, managing and providing oversight for all regulatory deliverables and outputs, required regulatory project management activities, internal interface interactions, governance meetings and documents/presentations and resulting deliverables as well as the supportive external strategic partners activities for the assigned portfolio of product(s).
  • Taking "Hands-on" accountability by managing Regulatory Strategic Partner and Stakeholders yourself effectively in line with agreed global regulatory strategy, and within agreed timelines
  • Providing strategic planning expertise
  • Ensuring effective communication of regulatory strategy, risks, and overall plan for assigned regions to Global Regulatory Affairs Practice Teams and business units as agreed with the Global Regulatory Lead
  • Proactively identifying areas for improvement. Initiating improvement projects together with Regulatory Strategic Partner and Stakeholders.

 

Interested? For this position you’ll need the following education, experience and skills:

  • Bachelor's Degree in relevant life sciences or business-related discipline
  • Minimum of 5 years of experience in a regulatory environment (pharmaceutical industry or a regulatory authority) including relevant experience in Global Regulatory strategy and submissions management and interacting with key Global Health Authorities
  • Proven Partnership Management experience (working with or within CRO or vendors also including contract management, finance and budget)
  • Demonstrated competence in contributing on cross-functional teams and operating within a matrix organisational structure
  • Influencing skills - through well thought through rationale and effective communication skills, able to influence key decisions
  • Flexibility and adaptability - Decides what to do based on the situation. Changes behaviour or approach to fit the situation or the person. Works effectively in ambiguous situations.
  • Communication skills – knows when and how to communicate, using strong interpersonal skills and written communications when appropriate
  • Results focused – ability to overcome obstacles and achieve key outcomes
  • Organizational Skills
  • Integrity – overriding commitment to integrity and high standards in self and other

 

To apply please go to www.ucb.com/careers.

Discover more about the remarkable UCB Talent Blends and how you can contribute to the mix at www.ucb.com/careers.

 

 

 


Job Segment: Regulatory Affairs, Law, Pharmaceutical, Compliance, Legal, Science, Strategy

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