Regulatory Affairs Officer - work on MAAs , post approval and all aspects of regulatory work

Location
Oxfordshire
Salary
On Application
Posted
19 Nov 2018
Closes
19 Dec 2018
Ref
SD21567
Discipline
Regulatory Affairs
Contract Type
Permanent

Role - Senior Regulatory Affairs Officer.

Location- Oxfordshire

Salary:Negotiable

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)

Clinical Trials

Scientific Advice

Marketing Authorisation Applications

Regulatory Submission Strategy

Orphan Medicinal Product Designation in the EU

Paediatric Investigation Plans

Post-Approval Activities

Variations

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

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