Regulatory Affairs Officer - work on MAAs , post approval and all aspects of regulatory work
- Contract Type
Role - Senior Regulatory Affairs Officer.
This leading European consultancy is looking to hire a couple of regulatory affairs officers who have at least 3-4 years experience in European , MAA and Post approval work. You will be learning on the job and picking up other skills and experience in regulatory affairs that you don't already.
The Consultancy has expertise in the following areas so you will gain experience in these scientific fields as you go:
nvestigational Medicinal Product Dossiers (IMPDs)
Investigator Brochure (IBs)
EU Clinical Trial Authorisation (CTA) applications
US Investigational New Drug (IND) dossiers
Common Technical Document (CTD) Overviews and Summaries
Marketing Authorisation Applications (MAAs)
New Drug Applications (NDAs)
Marketing Authorisation Applications
Regulatory Submission Strategy
Orphan Medicinal Product Designation in the EU
Paediatric Investigation Plans
EU Small- and Medium-sized Enterprises (SME) Status
Additional Regulatory Activities
We offer an enjoyable working environment, the opportunity to work on a wide range of projects with a variety of clients, and we welcome employees' contributions to influence the evolution of our company as we grow.
In addition to providing services for our clients, several of us are active contributors to conferences such as PhUSE, CDISC, and DIA. We encourage our consultants to get involved in initiatives that interest them.
In the team, you will be colleagues with experts in your field and part of a team where everyone openly shares their experiences and expertise. They have a relaxed and informal working environment at the office, and there are often opportunities to work in a team with colleagues in the client setting as well.
Flexibility is one of their core values, and in addition to offering flexible solutions to their customers, they also strive to tailor each position to suit the employee's individual requirements and personal situation. They believe that work-life balance is vital to the performance of the company as a whole. They do our best to accommodate flexible working hours.
Key words / key word: regulatory affairs , reg , regulatory , regulatory affairs officer , MAA , Oxford , Berkshire , Oxfordshire, Post Approval , EU , USA