Associate Director, Regulatory Affairs - Hertfordshire

Key People

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Job ID :

8005


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Hertfordshire,Hertfordshire,


Key Skills :

regulatory affairs, associate director, senior manager, cta, pips, pip, centralised procedure, CP


Salary :

£65000 - £73000 per annum + car allowance, bonus and usual benefits


Date Posted :

26 Jul, 2017



Company Name :

Key People


Location1 :

Hertfordshire




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

upto 15%





Description

An excellent opportunity has arisen for an Associate Director, Regulatory Affairs to join a global pharmaceutical company based in Hertfordshire. Within this role you will oversee the submission of global submissions, ranging from CTAs through to registrations and post approval.

Essential main job functions:
*Manage the schedule of regulatory submission's including MAAs for innovative regulatory pathways (CP, MRP and National Procedure), variations and renewals
*Prepare and submit MAAs 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
*Participate in the preparation and management of the regulatory budget process
*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, please contact Tim Barratt on +44(0)1727 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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