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.
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.
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 held with the client in order to discuss any issues, delays or concerns. Three batches require import laboratory testing prior to QP release to market.
Achievable – All targets set when seeking new contracts must be realistic and profit making.
Relevant – It is imperative that AndersonBrecon UK help develop new products alongside new clients in order to meet the company’s vision “To be the preferred partner to healthcare providers and pharmaceutical manufactures”.
Timescale – In order to ensure this task is completed on time all the departments involved need to work together and managed in an efficient and organised manner.
Setting Team Objectives from Organisational Targets
SMART Plans were used to set the objects.
Specific – The client provided AndersonBrecon UK with approved analytical methods in order to aid the laboratory with the import testing.
Measurable – All analytical tests will be listed, allocated and assigned to the most appropriate person within the laboratory. Expected completion dates will be set, weekly progress meeting held to monitor the project and the associated tasks. The goal is to complete all the tasks by the 08 February 2013.
Achievable – AndersonBrecon UK is a consulting services company which specialises in developing new products therefore it has all the relative resources to hand to ensure this is achievable.
Relevant – Every task listed will need to be relevant to the task in hand. Due to tight time constraints any irrelevant tasks will result in wasted time.
Timescale - It is imperative that the analytical tests are performed and results reviewed in time for the product launch and therefore it is extremely important that all the tasks planned and allocated are completed on time and in full.
Specific – The client provided Regulatory documentation, licensing documentation, marketing authorisation documentation, manufacturing batch records and...