Regulatory Science Lead - Immunology

UCB - Union Chimique Belge

Slough, United Kingdom

The Regional 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.

What you’ll do:

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
Serve as the primary regional point of contact for the Global Regulatory Lead, affiliates, and other Practices/Functions
If applicable, responsible for facilitating and coordinating the regulatory regional product team in collaboration with Global Regulatory Lead to ensure that objective priorities are met.
Primary contact point with the regional 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.

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

Bachelor’s degree, master’s preferred
Several years hands-on experience in Regulatory Affairs, with knowledge of assigned regional regulatory procedures and legislation for complex therapeutics.
Preferably experience within Life Cycle management & development projects.
Communication skills - knows when and how to communicate, using strong interpersonal skills and written communications when appropriate.
Build effective partnerships - identifies opportunities and takes actions to build effective relationships within team and with other areas.
Facilitates and coordinates teams and processes with appropriate use of interpersonal skills

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