The Pharmaceutical & Regulatory Affairs Department works in accordance with the principles and regulations of both National and European agencies relating to the quality, safety and efficacy of medicines and is split into 3 key areas of responsibility:
- Regulatory Affairs (including Product Development) – who work closely with internal departments and the Regulatory Authorities to achieve the following key approvals for the Company: clinical trial applications, Paediatric Investigation Plans (PIPs) and new marketing authorisation applications as well as the sourcing and manufacture of clinical study supplies.
- Clinical Supplies – work closely with internal departments and approved external vendors to manage the following key activities for the Company: packaging, labelling, release and distribution of investigational medicinal products for use in global clinical studies, oversight of electronic randomisation and clinical supply stock management systems, and ultimately destruction of returned/unused material at end of study.
- Lifecycle management of Marketed Products – work closely with internal departments and the Regulatory Authorities to achieve the following key approvals for the Company: marketing authorisations in new countries/territories, changes (variations) to the product licence particulars, licence renewals, line extensions for new formulations as well as the creation of product technical files, review of data generated to support marketed products.
The level of activity ranges from coordination and support of technical and scientific activities relating to regulatory submissions or clinical supplies at the Associate level to developing strategy and overseeing delivery at a Senior Management level.
Employees in this function generally start at Associate level with a degree in a scientific or technical subject and experience in other areas of drug development. Through internal/external training these individuals develop basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures. With experience they can move into management and senior management roles and take on responsibility for a portfolio of compounds /products on a regional level while contributing to the global strategy.
Working on projects in a smaller company, empowers me to learn and ultimately manage every aspect of the project.
I’ve worked for four different Japanese Pharma companies and working for MTPE is definitely the best as you are asked to ‘make it happen’.
Extra working time taken as 1/2 day flexi off is very valuable and gives me the flexibility we all need.
Even from the first interview, it was clear that MTPE encourages the continuation of professional development, education and revalidation activities – Pharmaceutical Physician Trainee ST5.
The company takes a scientific and evidence driven approach to drug development – this is a major attraction for me.
It’s fabulous to be able to combine working in a global pharmaceutical company in the heart of a city, furthermore, in the City of London. There are not many chances to do this!
I used to drive 1 hour each way to my previous office via the M4 and M25. However, having the MTPE office in the city makes my commute a lot easier and allows for a healthier lifestyle.
Good, competitive salary and benefits package.
I have not previously worked within a Japanese pharmaceutical company and I really enjoy it.
As a Pharmaceutical Physician in training with the Faculty of Pharmaceutical Medicine, MTPE offers an ideal environment for any physician regardless of training stage. There is ample opportunity to be involved in a variety of projects which provides significant scope for accomplishing the required learning outcomes while providing a broad breadth of experience.
You will be given a breadth and vision of what is expected of you and encouraged to utilise your expertise to the full.
The responsibility and broad range of roles available for the small sized growing companies has enhanced my capability and ability as a business person.
Excellent office location, close to Brick Lane, Shoreditch and Spitalfield Market if you want to get a ‘taste’ of east London or just enjoy east end culture.
Certainly the job is exciting, but it is the wide role and open-remit of the job that is the invigorating element.
Flexitime means suddenly 10 or more minutes later does not matter that much, and if your tube or train refuses to cooperate with your travel, you are still on time in the office.
Being a mid-sized set-up within Europe, my first experience within Pharma has allowed me to use all my strengths as a Project Manager and Manager, whilst getting involved in the early stages of Drug Development. This is a unique opportunity which I am very lucky to have had thanks to MTPE.
I’m impressed by the full suite of employee benefits, you hopefully won’t ever have to use them all but at least they are there in case you do.
MTPE’s approach to resolving challenges is different to that of all other of the nine Pharmaceutical companies I’ve worked at.
Although MTPE’s business size is still small in Europe, it has great potential to grow as a subsidiary of one of the biggest pharmaceutical companies in Japan which is also a major affiliate of one of the world’s biggest chemical companies. This motivates me to work here in MTPE.
I have now been at MTPE for almost 5 years after working internationally – The attractions are for me : its small size and the opportunity to be involved in local project teams including a broad variety of functions, backgrounds and nationalities.
Good collaboration with our Japan based HQ colleagues.
I feel that MTPE is an excellent place to work, in a great location, with exciting projects and with the truly global experience that only comes with working for a Company of Japanese origin.
The flexi time system has ensured I can meet both my work and personal priorities – it makes my weekly juggling act easier.
Very nice, friendly and extremely professional people from nearly 30 nationalities – this is what I consider a truly international working environment.