You must be logged in to apply for this position. Log in using the form on the right, at the top of the page beneath the logo, or click here to register.
Regulatory Affairs Manager in Submissions Compliance (QC) - Office and Home based - South East
The Company
An excellent opportunity to work with a top global Pharmaceutical company who are currently developing a number of diverse and exciting products. Working within this large company and Regulatory Affairs department, will be a fantastic opportunity to broaden your experience, enabling you to take your next step up the career ladder!
The role
The position requires an experienced Regulatory Affairs professional who has a good eye for detail and is an excellent communicator, enjoying the variety of liaising with a number of internal and external departments. In this position, you will be responsible for the review and QC of regulatory documentation and submissions e.g. (CTA s, IMPDs, MAA/Variations). The Manager will liaise with RA staff in R&D & Marketed Products Groups as well as internal R&DGroups and external CROs and vendors as appropriate, and maintain regulatory documentation and systems. For very experienced candidates, there may be the option of working 2-3 days/week home-based.
Main Responsibilities:
• Accountable for the quality and reliability of submission documentation
• Review and QC of Regulatory submission documentation prior to publishing/printing.
• Provision and interpretation of appropriate directives and guidelines as projects require to appropriately guide timely research and development activities
• In the International Project Team setting, may be responsible for regulatory input into R&D projects with respect to QC of documentation.
Qualifications and education required:
• Degree in Life Science
• Significant previous Regulatory Affairs experience (including building/ project co-ordinating or critical review of IMPDs or MAAs and component documents)
• Working with Regulatory Publishing groups/Operations groups
• Working with clinical, non clinical and CMC documentation (some exposure in each area would be valuable)
• Electronic submissions (preferred)
Key Words: Manager, Regulatory Affairs, Regulatory Affairs, Submissions Compliance, QC, Quality Control,Regulatory Submissions, Regulatory Documentation, Electronic Submissions, MAAs,CTAs, Variations, Renewals, Hertfordshire, North London, Bedfordshire, Essex, Relocatable, South East, West London
You must be logged in to apply for this position. Log in using the form on the right, at the top of the page beneath the logo, or click here to register.
.gif)
Site by Redder