Principal Regulatory Executive 6 Month FTC

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Amar Annamalai
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Principal Regulatory Executive 6 Month FTC

Principal Regulatory Affairs Executive 6 Month FTC - Pharmaceutical - Middlesex

Experienced Regulatory Affairs professional wanted to join a highly successful pharmaceutical company as a Principal Regulatory Executive on a 6 month fixed term contract basis, the role will be office based in Middlesex.

This well established and pioneering pharmaceutical company is a market leader in the development, manufacture and bringing to market of specialty medicines throughout Europe. They are committed to improving quality of life for patients suffering with a variety of serious illnesses such as gastroenterology, hematology and incontinence.

As the Principal Regulatory Affairs Executive for the German and Swiss regions you will be responsible for leading cross functional project teams, planning submissions and producing quality regulatory documentation for submission. You will liaise with relevant departments and regulatory authorities whilst supervising more junior regulatory team members.

Key Responsibilities:

?Prepare, plan and submit regulatory submissions according to guidelines
?Communicate with internal and external contacts
?Seek approvals from regulatory authorities
?Provide regulatory expertise
?Maintain thorough regulatory knowledge
?Communicate any regulatory changes
?Produce product labeling
?Identify and resolve regulatory issues
?Participate in and lead cross functional project teams
?Maintain regulatory paper and electronic databases
?Provide regulatory information for use in monthly financial reports
?Ensure compliance

You will possess a relevant scientific or medical degree, you must have a minimum of 3 years pharmaceutical regulatory experience gained across the German and Swiss regions where you have worked with the relevant authorities and previous exposure to CMC, new product registrations and life cycle management is essential. You should be a customer focused natural leader who works equally as well as part of a team and who has excellent interpersonal, organization and communication skills.

This dynamic, ethical and customer focused company value and reward talented professionals whilst encouraging training & development and an entrepreneurial approach. They are offering many benefits including a competitive salary, a bonus scheme, a pension plan, private healthcare, life assurance and a generous holiday entitlement to name a few.

Key Words - Pharmaceutical, Regulatory Affairs, Senior, Principal, Executive, Officer, Associate, Specialist, Manager, Consultant, FTC, Fixed Term Contract, CMC, German, Germany, Swiss, Switzerland, Uxbridge, Middlesex, UK, United Kingdom, EU, Europe

For further information on the role or company please contact Amie Adams at Paramount Recruitment on 0121 616 3473.
Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.

Deadline:10 January 2014

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