Regulatory Affairs Executive

My client, a generics pharmaceutical company in the Berkshire area, is looking for a Regulatory Affairs Executive on a permanent basis. This will be paying upwards of £25,000 plus benefits.

Job responsibilities include but are not limited to:

*Prepare and submit applications of reliable quality in a timely manner to MHRA (UK) via National Procedure. These include new licence applications, variations (including grouping and work sharing), renewals, artwork changes, RFIs, updates and any other relevant applications or notifications.
*Have a good understanding of and be able to execute activities related to the following key areas
oVariations: Type 1A, 1B, II, Labelling changes including own label supplies, safety updates and line extensions
oReclassification of Medicines
oRe-baseline / Remediation dossiers
oMaintenance of Marketing Authorisations including renewals
oDeficiency responses to authorities
*Partake in the interfacing with regulatory authorities to facilitate the approval of submissions
*Act as a point of contact for other business units, customers, and internal/external teams
*Stay informed about new and changing regulatory requirements and ensuring compliance
*Liaise with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome

Required Skills
*Pharmacy/Chemistry degree
*Ideally 3+ years of Regulatory Affairs experience with a focus on Post Approval activities
*Significant experience in submitting complex Type 1A, 1B, II variations
*Understanding of the current UK and European regulations, laws, guidelines and industry requirements.
*Exposure to NeeS/eCTD format and electronic submission gateways is preferable.
*Experience with Generic products and MRP/DCP submissions is advantageous.

Additional Experience
*Attention to detail and able to produce quality documentation
*Good interpersonal skills
*Effective oral and written communication skills
*Excellent organizational and planning skills
*Ability to work independently
*Ability to interpret data and draw meaningful conclusions

If the above may be of interest and you feel as though you're profile is suitable, please do apply and feel free to get in touch with Ross Wilson at rwilson@keypeople.co.uk for further information.