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.
