Overview

Reference Number: JO-2212-506537
Regulatory Operations Manager
Rate: Negotiable
Job Type: Permanent
Location: Cambridge

Job Title: Regulatory Operations Manager

Location: Uxbridge or Cambridge – Hybrid working

Salary: Up to £70,000 plus package (Bonus, Stocks, benefits)

A Top 10 global Pharma is now looking to grow their Regulatory operations team with the hire of a Regulatory Operations Manager who will work as part of a global team, responsible submission management and publishing for developing and established products.

To be considered for this role you will need to have a strong background within Regulatory operations/Publishing, with a good knowledge of eCTD and various regulatory systems. This is an exciting opportunity to work in an experienced team and get exposure to a full range of submissions with plenty of opportunity to develop your career.

Responsibilities:

–         Publish and oversee complex submission publishing process development

–         Submission/Publishing lead for Regulatory Operations, building strong relationships with the Global Regulatory team

–         Submission planning, tracking, resourcing and strategic advice and guidance within cross functional teams

–         Oversee preparation of complex submission compilation activities

Experience:

–         Expert knowledge of Regulatory Operations

–         Strong project management experience

–         In-depth knowledge of eCTD

–         Experience in document management and regulatory publishing

–         Good breath of experience managing submissions for developing and marketed products

For further details please apply with an updated CV and I will be in touch to discuss this further.

Chris.bart@cpl.com