Global Delivery Senior Manager

Highly Competitive
  1. Permanent
  2. Publishing & Submissions
  3. United Kingdom
Berkshire, England
Posting date: 01 Jul 2020
30278

An exciting opportunity has arisen for a Senior Global Delivery Manager at a multinational biotechnology company in Berkshire. The bright individual will be able to step up and grow organically within the company which is perfect for an individual who is looking for a career development.

Job Responsibilities

  • Responsible for global electronic submissions and documents meeting regulatory agency and internal submission standards and technical requirements.
  • Demonstrates expert knowledge of submission or technology-related Global Health authority guidelines/regulations.
  • Oversees publishing deliverables and vendor activities on a day to day basis to ensure successful execution of operational activities for assigned products.
  • Internal influencing, socializing and communication of changes.
  • Responsible for understanding and communicating impact of Industry / Agency changes relevant to submission sciences, in partnership with vendor and driving innovative process change for improved efficiency.
  • Coordinates and tracks delivery of required content with content owners for routine / maintenance submissions in all markets.
  • Maintain current regulatory knowledge and keep abreast of regulatory procedures and changes related to the electronic Common Technical Document.
  • Interprets, implements, and ensures compliance with relevant revised and new FDA/ICH/global eSubmission regulations.
  • Acts as a liaison between members of submissions and other functional areas in order to ensure timely submission of regulatory-compliant, quality documents.

Skills and Requirements

  • 6 to 8+ years pharmaceutical and regulatory experience (biotech products preferred)
  • 4 to 6+ years regulatory operations experience
  • SME in eCTD
  • SME in regulatory operations processes
  • Strong communication and project management abilities in global and virtual teams
  • Competent in the use of electronic document management and submissions publishing tools.
  • Flexibility, proactive, attention to detail, demonstrated accountability for deliverables, and proven ability to work independently is expected
  • Bachelor's Degree (life sciences preferable, IT/Business acceptable)

To Apply

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Alex Czuprynski, alex@proclinical.com or upload your CV on our website - www.proclinical.com/send-cv

A full job description is available on request.

#LI-AC1

#Regulatory

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