Regulatory Affairs Manager

Key People

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Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :


Address 1 :

United Kingdom,Hertfordshire,Hertfordshire,

Key Skills :

regulatory affairs, manager, marketed products, post approval, CMC, hertfordshire,

Salary :

£55000 - £65000 per annum + bonus and benefits

Date Posted :

26 Jul, 2017

Company Name :

Key People

Location1 :


Job Category :

Regulatory Affairs Jobs

Experience :


Job Type:


Travel Amount:



Reporting into the Head of Regulatory Affairs, within this role you will be responsible for the registration of new products and the maintenance of existing products.

Essential main job functions:
*Manage the regulatory submissions including Marketing Authorisation Applications for innovative regulatory pathways (Centralised Procedure, Mutual Recognized Procedure or National requirements), Variations and Renewals.
*Prepare and submit Marketing Authorisation dossiers in Europe and Rest of the World
*Responsible for the regulatory management of medical devices (Europe and Rest of the World) either for manufacturer or distributor
*Establish key contacts within the various Health Authorities
*Responsible for creating, updating, reviewing and approving product information (leaflets, labels, boxes, SPCs etc.) and promotional materials

Additional Requirements:
*Management of the CMC activities with in line with pharmaceutical development, maintenance and strategy
*Maintain a strong working relationship with the medical/pharmacovigilance and marketing/ commercial teams
*Contribute to the implementation of the regulatory strategies for new product
*Manage regulatory intelligence
*Involvement with reimbursement/pricing dossiers

Experience/qualifications required:

*Excellent communication skills
*Ability to build relationships with key stakeholders both internally and externally in order to obtain quick approvals
*Able to work independently, with moderate supervision on multiple projects and within multi-disciplinary teams
*Previous experience of regulatory requirements for launching a new product
*Second European language ideal but not essential
*Educated to degree level or equivalent

For further details about this role, please contact Tim Barratt on +44(0)1727 817 626 or email

Company Name:

Key People


Catherine House,Adelaide Street


Staffing Firms


United Kingdom





less than 100




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

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