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EU Reg. Science Lead & Reg. Affairs EU

Location: 

Anderlecht, Brussels, Belgium

Job Function:  Regulatory Affairs
Job ID:  69491

The European Product Lead is responsible for all regulatory activities related to product development and marketing authorizations in the region and is the primary contact point within UCB for any regulatory issues with the product and with designated health authorities. 

 

This role can be based in either our HQ in Brussles, Belgium or in our UK Headquarters in Slough, United Kingdom or in our French office in Paris, France. 

 

MAJOR ACCOUNTABILITIES

 

  • Develops and implements the regional regulatory strategy and plan consistent with the business objectives, inputting regional expertise into the global regulatory strategy and global planning in line with the Global Regulatory Lead (GRL).
  • Serve as the primary regional point of contact for the GRL, affiliates, and other Practices/Functions
  • Responsible for facilitating and coordinating the regulatory regional product team in collaboration with GRL to ensure that objective priorities are met.
  • Primary contact point with the European health authorities building strong relationships
  • Responsible for ensuring that the regional regulatory strategy for the specific product(s), have been negotiated (if appropriate) with the regional health authorities and that the regulatory risks have been identified and mitigated
  • Responsible for ensuring that the regional regulatory strategies, risks and mitigations and overall plans are effectively discussed with, endorsed by and communicated to the GRL, GRA European Head, GRA LT, and other functions and affiliates as needed
  • Coordinate the regional submission team
  • Deliver regulatory submissions in line with the applicable regulations, directives and guidelines, and in line with agreed strategies and timelines.
  • Ensure that all documents and information are adequately captured in a timely fashion in the applicable systems (document management, databases, etc).
  • Prepare and communicate regulatory strategic and operational plans for assigned projects
  • Assist in development of regulatory standards, efficient processes and SOPs
  • Maintain awareness of UCB and competitors’ activities in the region and share potential impact these activities may have on the product development program
  • Maintain awareness of external regulatory environment, new guidelines and legislation.

 

BUSINESS KNOWLEDGE AND TECHNICAL EXPERTISE

 

5 to 10 years pharmaceutical experience (or equivalent experience) in Regulatory Affairs working with cross-functional and international teams and with knowledge and experience of regional regulatory procedures and legislation related to two or more of the following: drug development, product registration, line extension or license maintenance, with a priority to drug development and product registration.

 

MANAGEMENT AND LEADERSHIP SKILLS:

 

  • Facilitates and coordinates teams and processes with appropriate use of interpersonal skills
  • Build effective partnerships - identifies opportunities and takes actions to build effective relationships within team and with other areas
  • Influencing skills - through well thought through rationale and effective communication skills, able to influence key decisions
  • Communication skills - knows when and how to communicate, using strong interpersonal skills and written communications when appropriate
  • Sensitivity to the diverse cultures comprising- the international and global environment

 

DELIVERING SOLUTIONS

 

  • Strategic and results focused - ability to overcome obstacles and achieve key outcomes
  • Strong Project planning and management skills, being able to perform risk assessments, anticipating problems and providing creative solutions.
  • Analytical - logically breaking situations or issues down into their essential elements: carrying out diagnosis and developing solutions
  • Integrity - overriding commitment to integrity and high standards in self and others
  • Flexibility and adaptability - Decides what to do based on the situation. Changes behavior or approach to fit the situation or the person.  Works effectively in ambiguous situations.

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