• Senior Manufacturing Expert Jobs in United Kingdom - 23296354

  • Iqvia
  • United Kingdom, Uk
  • Save Job
  • 10 - 13 Years
  • Posted : above 1 month

Job Description:

Drives the Quality/CMC content work in offering development projects expanding and improving the quality of the applicable regulatory content
Owns (in partnership with the content manager) the Quality/CMC content in Tarius including the relevant expert summaries and cross-country tables covering all countries
Responsible for ensuring the content quality standards are met at all times
Responsible for providing high-quality impact assessment of key regulatory documents EU and US
Collaborates with Local experts and Tarius Editorial Team on aspects related to the CMC content
Responsible for knowledge-sharing and training within the CMC area
May participate in client meetings as subject matter expert on the clinical trial regulatory content

Required Knowledge, Skills and Abilities

10 years of experience within manufacturing regulatory area (preferably from pharmaceutical company)
In-depth knowledge on Quality/CMC regulatory including Requirements in all phases of drug development (phase I-IV studies)
Clinical trial requirements
Regulatory processes and approval times
Understanding of manufacturing processes
Ability to assess impact of new regulatory requirements EU and US

Good understanding of the Research and Development process as well as the manufacturing processes within drug development
Masters degree or equivalent
Excellent English skills
Experience in working in a project setting
Knowledge of the pharmaceutical industry and its challenges
Business understanding/acumen
Ability to create strong working relationships across organisation (local experts, editors, consultants and external partners)

Key Characteristics

Proactive, Detail oriented, knowledgeable, consultative, problem solver, customer focused, creative, resourceful, fast & flexible, team player, organized

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Consulting Services
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 01st Feb 2020

Key Skills:

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