We are growing, grow with us!
Would you like to work in a dynamic company with daily new challenges and opportunities? Then, PharmaLex is your career opportunity.
PharmaLex is one of the leading service provider company for the global Pharmaceutical Industry and is specialized in all aspects of drugs and medical devices approval, of the development to market and any action to product maintenance make it as effective as possible.The success of our company comes with the excellent expertise and the high motivation of our employees.
If your profession is not only a job but a mission too, and you enjoy working with people, then you are more than welcomed to join us.
To strengthen our successful team PharmaLex team in the UK, we are looking for a:
Regulatory Affairs ManagerAs a part of our Regulatory Affairs team, your duties will primarily include planning, preparation and submission of regulatory documents.
- Supporting new marketing authorisation applications
- Conduct post-authorisation maintenance activities e.g. variations, MAH transfer, renewals and response to questions
- Communication with clients, regulatory authorities and other functions e.g. artwork, non-clinical and clinical teams
- Gap review and compliance activities
- Compilation and submission of clinical trial applications
- Conducting electronic publishing activities
- Supporting patient information leaflet testing / bridging and product information preparation
- Academic degree in pharmacy or life science
- 3 – 7 years of experience in Regulatory Affairs
- Well organized, attention to detail, sense of accuracy and right first-time approach
- Delivery at consistently high standard, whilst striving to exceed expectations
- Excellent communication skills in English, written and verbal
- Flexible and committed to meet deadlines
- Assisting with new business enquiries
- Making a positive and relevant contribution to the industry
- Aptitude to support and train more junior members of the team
- Coordination skills
- Team player
We offer you
- Diversified and challenging job
- Open and collaborative organisational culture with emphasis on knowledge-sharing
- Flexible working hours
- Continuous development opportunities through knowledge and experience as well as training
This offers exciting and varied challenges in a friendly team, fantastic environment as well as presenting further opportunities for personal development and job training.
On offer is an opportunity to work in one the most beautiful counties in the UK. Surrounded by the sea, stunning beaches, clean fresh air, safe communities with low crime rates. There are a whole host of activities on offer, join a gig rowing club, learn to surf, take up horse riding or maybe learn the Cornish language. Enjoy high quality local food from artisan producers and Michelin star restaurants to quaint tea rooms, local bakers and farmers markets in most towns.
It really is the most amazing place to live and work and we are committed to ensuring your work life balance allows you to enjoy it to its full. Swap the long commute in a packed train or on a grid locked road for fish and chips on the beach with the family or a quick surf for one after work.
We are only 40 minutes from Newquay Airport where you can fly to London and Manchester in 1 hour 10 and Birmingham in 1 hour. You can also fly directly out of Newquay to a growing number of cities abroad.
If you are interested to join our PharmaLex team taking over this challenging job opportunity in our future-oriented company, we look forward to receiving your application documents stating your earliest possible starting date and salary expectations online.
For further information please don’t hesitate to contact us:
Ms Laura Escabias
Senior European Recruitment Specialist
Contact phone: 0034 912 16 39 49