Regulatory Affairs Manager

Key People


Job ID :

8010


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


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 :

Hertfordshire




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

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 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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