Regulatory Affairs Manager
- Regulatory Affairs
Regulatory Affairs Manager- Permanent.
Central London, UK
Extremely Competitive salary and benefits package including monthly car allowance and bonus!
An incredible opportunity has arisen for a Regulatory Affairs Manager to join a leading research-based bio-pharmaceutical company with an incredible portfolio of life changing treatments. Our client has a fantastic brand culture and a passion for innovation and simplifying the care needed to treat life threatening illnesses.
Coming from a strong UK/Ireland affiliate focused Regulatory background, you will be expected to:
-Author and submit all UK/Ireland Clinical Trial Applications, as well as post-approval variations.
-Assist in developing UK and Ireland affiliate commercial strategy.
-Review and approve promotional and non-promotional material.
-Liaise with MHRA and HPRA competently.
-Convert centralised applications to national licenses.
-Advise the branding team accordingly based upon collated Regulatory intelligence.
-Operational involvement in eCTD publishing activities.
As a successful applicant, you must have:
-A minimum of 4 years working in a UK/Ireland affiliate Regulatory position
-A scientific bachelors or Masters degree
-Highly proficient in filing national variations to the MHRA/HPRA.
-Experienced in managing Clinical Trial applications, including amendments and other Clinical Trial relation submissions.
-Experience in GXP compliance and eCTD publishing is advantageous, but not essential.
If this role is of interest to you, and you would like to have a confidential more in-depth discussion regarding this position then please get in touch on 01189522797.
Alternatively, feel free to email me your CV to me for immediate consideration.
If this role is not quite right, no worries at all. If youre interested in hearing about other great career opportunities, then please still get in touch as there are numerous Regulatory requirements at the moment. Additionally, if you know someone that may be interested in this role then we reward 250 worth of vouchers for every successful placement so please let me know!