Regulatory Affairs Director - Pharmaceuticals - Circa £90,000 - Home based role
Have you over vast experience in European regulatory affairs?
Are you also familiar with US FDA requirements?
Quay Recruitment are currently recruiting for a leading pharmaceutical business that provide specialist regulatory services to the pharmaceutical industry. This is an excellent opportunity to join this organisation as they continue their growth and they are looking to add a Regulatory Affairs Director to their senior management team.
As Regulatory Affairs Director, you will have the following job roles and responsibilities:
* Lead EMA procedures including orphan applications, PIPs and MAAs
* Assist with Business Development activities by taking part in new prospective client-lead discussions
* Provide expert EU regulatory strategy
* Provide leadership in scientific advice meetings at national agencies and EMA
* To assist the senior management team by providing leadership support to a team of internal consultants and their clients
In order to be suitable for the position of Regulatory Affairs Director, ideally you will have the following as a minimum:
* Degree or higher in Chemistry, Biochemistry, Biology or related scientific disciplines
* Demonstrable experience in centralised MAAs, orphan applications and PIPs
* 5+ years European regulatory affairs experience with demonstrable experience in liaising and negotiating with regulatory authorities and point of contact with EMA
* US FDA experience would be very desirable
The successful candidate for the role of Regulatory Affairs Director will be rewarded with the following package:
* Salary of circa £90,000
* 25 days holiday plus bank holidays
* Company pension scheme up to 5% contribution
* Home working position with occasional head office meetings
The vacancy of Regulatory Affairs Director is a UK home based role though would suit candidates based in London, Herts, Essex and Home Counties areas.
Other job titles may include: RA Director, Associate RA Director, Regulatory Affairs Specialist, Head of Regulatory Affairs
If you wish to discuss this role in more detail please click apply for a confidential discussion of the job spec, company profile and culture and to run through your CV