Specialists in Pharma, Clinical & IT Recruitment

Regulatory Affairs Manager

Reference:
RAMUKCRO
Job Type(s):
Regulatory Affairs
Salary:
Salary negotiable
Town/City:
Berkshire
Contract Type:
Permanent
Date Posted:
18/10/2013 16:25:00
Start Date:
18/10/2013
End Date:
13/12/2013

Description

My client a global Clinical Research Organisation has opened a new vacancy within their Regulatory Function.

They are actively seeking to recruit a Regulatory Affairs Manager to their team on a permanent basis in Berkshire, UK.

The Role: 

·         Be Responsible for UK Regulatory Submissions, including CTA’s, IMPD’s, EC Submissions.

·         Submissions of Protocol amendments and Investigator brochure updates.

·         Provide General Regulatory guidance of junior team members.

·         Responsible for Developing and implementing Regulatory Strategies.

·         Providing guidance on compliance issues.

·         Keeping upto date with changes in local Regulatory Legislation.

·         Working closely with other internal departments to assure timely submissions of regulatory documents.

 

Skills/Experience Required

·         Life Sciences Degree.

·         Minimum 3 Years’ experience within Regulatory Affairs, ideally within a Clinical Research background.

·         Excellent understanding of GCP-ICH Guidelines.

·         Familiar with the UK Regulatory Market.

·         Fully eligible to work in the UK.

 

For more information regarding this vacancy or a confidential job discussion, please get in touch with Neal Panting. Neal@arc-7.com or +441483 397070

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