Specialists in Pharma, Clinical & IT Recruitment

Regulatory Project Manager

Reference:
RPMUK
Job Type(s):
Regulatory Affairs
Salary:
Salary negotiable
Benefits:
Excellent Benefits
Town/City:
Surrey/West Sussex
Contract Type:
Permanent
Date Posted:
24/10/2013 11:37:00
Start Date:
24/10/2013
End Date:
26/12/2013

Description

My Client and expanding Regulatory affairs Consultancy have opened a new vacancy within their Regulatory Affairs team. They are actively seeking to hire a Regulatory Affairs Project Manager to their team in Surrey.

The right profile will have:

Minimum 10 years’ experience of European and FDA requirements for the regulation of medicinal products and drug-device combinations, gained within a CRO or industry environment;

Experience of regulatory agency liaison and negotiation;

Ability to source local regulatory expertise across the EU and build a pan-European consultant network;

In-depth knowledge of the CMC requirements for marketing authorisation applications; working familiarity with nonclinical, clinical and pharmacovigilance requirements;

Ability to prepare, review, critique and compile marketing authorisation applications;

Knowledge of the clinical trial application process in the EU.;

 

My client would like a graduate scientist in a life preferably at PhD level, with the following skills:

A customer-focussed approach;

Confident, knowledgeable, diplomatic, reassuring and presentable to clients at all levels;

Strategic thinking, innovative, proactive, problem-solving;

Excellent command of English and strong organisational, communication, literacy and numeracy skills;

Ability to manage and prioritise multiple tasks, often to tight deadlines;

The ability to work on own initiative or as part of a team and assume responsibility for project leadership;

An eye for detail and the ability to critique documents for compliance with current guidance, scientific accuracy, and presentation;

Previous exposure to business development practices and a desire to help grow the business.

 

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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