Employed as a Compliance and Regulatory Affairs Officer at AndersonBrecon I am responsible for actively pursuing the streamlined introduction of new products within project timelines, setting up and maintaining Regulatory files, Preparation of annual Product Quality Reviews and general administrative duties.
Task
Recently AndersonBrecon UK was contracted to import and release a brand new medical product on behalf of a new client. I was tasked with the responsibility of ensuring that the project is managed and all of the regulatory documents are in place to allow us to release the product by February 2013. To list a few of my responsibilities; Implement new procedures, develop a process flow, write the Technical Agreement, collect Regulatory information and monitor the progress.
Organisational Targets
The targets are identified and set by the following company statements
Vision – To be the preferred partner to healthcare providers and pharmaceutical manufactures
Mission – To improve patient’s lives by delivering innovative products and services that drive quality and efficiency in pharmaceutical care.
Values – Accountability, collaboration, customer focus, innovation, integrity and passion.
These statements are referred to and implemented from the early stages of negotiating and securing the deal, right the way through to releasing the finished product to market.
The above Targets set by AndersonBrecon were identified using a SMART plan.
Specific - AndersonBrecon UK needs to build a good relationship with new clients in order to develop, grow and standard out in the market place. The goal is to proved product to the Market on time and in full. Departments involved in the task in hand are Regulatory Affairs, Warehouse, Laboratory, Qualified Person (QP) and compliance.
Measurable - As a company we need to ensure that the product is released in time for the Product launch date 08 February 2013. Weekly progress meeting are