This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies. Find out more here.

Close Message
NextPharmaJob.com for pharmaceutical industry jobs
Fforde Management
NextPharmaJob.com is dedicated to putting job seekers looking for pharmaceutical industry jobs in touch with recruiters and employers.

Similar jobs you may be interested in:

Head of Regulatory Affairs (m/w)
Switzerland
Regulatory Affairs Manager (m/w) Emerging Markets
Germany
Lead Statistical Programmer - Ireland
Ireland (Eire)
Senior Director, Statistical Programming
United Kingdom
Regulatory Affairs Specialist-Global Leader-Medical Devices
France
More...

To receive a FREE weekly email alert of all the latest pharmaceutical industry jobs added to our database enter your email address below.

Submit | Tell me more...

Sister site:
Our sister site
Job Details
This job has expired. Click here to view similar jobs.

Senior Regulatory Affairs Manager - Development



Business Type: Clinical Research Organisation
Job Type: Clinical Development, Clinical Study- Trials, CMC, Regulatory Affairs
Job Level: Not Specified
Position: Full Time
Salary: Competitive
Location: UK - South East
Reference: 17863/001
Closing Date: 14/08/12
Background:

Our client, a specialist global pharmaceutical company and innovative leader in pharmaceutical and health care research and development, is mainly concerned with development activities. They are seeking a Senior Regulatory Affairs Manager for their Buckinghamshire location.

JOB ROLE:
The Senior Regulatory Affairs Manager is responsible for the definition of regulatory strategy and subsequent implementation, in the European region (EU) and European economic Area (EEA). The Regulatory Affairs Manager will complete lifecycle management activities in line with legal/regulatory requirements and regional business needs.

PRINCIPAL RESPONSIBILITIES include:
Provide appropriate EU regulatory input to project teams
Plans and Implements regulatory activities in support of lifecycle management (renewals) and CMC maintenance in the region
Ensures effective planning, tracking, archiving of activities, especially submissions
Supports the communication of regulatory strategy in support of new product registration
Ensures that budgets and forecasts are developed and actuals managed in line with corporate requirements

QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
Life Sciences Graduate and prior experience in product development functions
Knowledge of both European pharmaceutical regulations and guidelines and national regulations within the assigned region
Proven track record in CP, MRP and/or DCP
Extended Regulatory Affairs experience

PERSONAL SKILLS & ATTRIBUTES:
Organisational and planning ability
Excellent negotiation skills
Excellent communication both written and verbal skills

BENEFITS OF THE ROLE: This leading pharmaceutical company is committed to fostering a friendly work place with no discrimination. They offer competitive annual salaries together with excellent benefits that include Pension Plan, Life Assurance, Private Medical Insurance, Disability & Accident Insurance, good Annual Leave, Performance related Bonus, Free Car Parking, Subsidised Restaurant, Sports & Social and more.

Fforde is acting as a recruitment agency/business.

KEY WORDS: Regulatory Affairs Manager, Development, Regulatory Strategy, Clinical Trials, Clinical Study, CMC, Life Science, Pharmaceutical, CP, MRP, DCP, CRO, Buckinghamshire



Posted: 17/07/2012 | NPJ Ref: 84205
line graphic

Compatible with:

JobMate   Broadbean

Site optimised for Internet Explorer 8+ / Firefox 3+
View a complete Jobs Listing



Credit cards image