Regulatory Affairs Executive

Key People

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Job ID :

15384


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Berkshire,Berkshire,


Key Skills :

Regulatory Affairs, Generics, Post Approval, Solid Dosage


Salary :

£25000 - £30000 per annum


Date Posted :

14 Oct, 2019



Company Name :

Key People


Location1 :

Berkshire




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

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.


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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