Regulatory Affairs Manager - Berkshire

Key People


Job ID :

15426


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Berkshire,Berkshire,


Key Skills :

regulatory, regulatory affairs, registrations, post approval, EU, US, manager, Senior Officer, berks


Salary :

£40000 - £60000 per annum + benefits


Date Posted :

04 Nov, 2019



Company Name :

Key People


Location1 :

Berkshire




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

I am currently recruiting for a Regulatory Specialist / Manager to join an exciting company based in Berkshire. Within this role you will work with the Head of R&D, to organise and manage the Regulatory Affairs function. This will include responsibility for performing, reviewing and approving regulatory affairs activities, including the application for New Product Registrations (MAAs), maintenance of existing Product Registrations (Variations and Renewals).
General Responsibilities:
*Management of Regulatory project work/project lead.
*Preparation and coordination or review of documentation or dossiers.
*Regulatory strategy (pre-submission or post-approval stages)
*Maintaining an awareness of the EU Regulatory landscape (Pharmaceutical & Device) and changing regulatory requirements

Key Responsibilities:
*Preparation and project management of Pharmaceutical Marketing Authorisation Applications (MAA) & Medical devices (STED)
*Artwork management on medical devices and pharmaceutical products.
*Preparation and review of responses to questions
*Preparation and review of post-approval/Variation and Maintenance submissions
*Dossier reviews and gap analyses
*Interact and negotiate directly with regulatory authorities and notified bodies. Assisting with Scientific Advice procedures

Knowledge and Experience:
*Proven experience in a similar Regulatory Affairs role working with pharmaceuticals/medical devices with knowledge of the Medical Device Directive (MDD), Medical Devices Regulation (MDR),
*Ideal candidate would have around 5 years' experience in Full lifecycle regulatory affairs within Pharmaceutical and or medical devices.
*Experience in developing regulatory affairs strategy, and interpreting, implementing and communicating regulatory changes, and developing team members.
*Knowledge of US and international medical device regulatory requirements, procedures, regulations

For further information, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk


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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