Regulatory Operations Lead

1 week ago


Slough Berkshire, United Kingdom Proclinical Staffing Full time

Proclinical is collaborating with a pharmaceutical company to find a dedicated and performance-oriented individual for a lead position in External Manufacturing Operations. Lead the operational management of Contract Development and Manufacturing Organizations (CDMOs) and vendors.
Serve as the primary contact for CDMO/vendor management, including relationship management and business support.
Manage projects and programs from early phase development to commercialization, including new product introductions and lifecycle management.
Provide technical support to affiliate teams overseeing local CMOs.
Support due diligence activities and implement industrial manufacturing strategies for local and global CDMOs.
Represent the External Manufacturing Team in transversal project and improvement programs.

Master's degree in a relevant field.
Significant operations management experience in a GMP environment, particularly in drug product and device manufacturing.
Experience in pharmaceutical project management.
Strong technical knowledge of pharmaceutical manufacturing.
Familiarity with regulatory requirements and best practices to ensure compliance and drive improvements.
Fluency in English. French would be highly desirable.
Ability to lead multi-functional teams, manage complex projects, and influence external business partners to deliver results.


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