CMC Regulatory Manager - External Manafacturing

Slough  ‐ Onsite
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Description

A leading Bio-pharmaceutical company with a broad and exciting portfolio are currently looking for a senior CMC Regulatory Affairs Specialist.
Candidate criteria;

*Proven significant experience in the biological field

*In-depth knowledge of EU regulatory requirements

*Strong Regulatory writing experience and familiarity of eCTD formats and publishing support functions

* At least 5 years experience in the preparation and submission of CMC fillings in US, European or EX-US content.
Job role;

*PrepareCMC sections of regulatory submissions

*Participate in development of regulatory strategy for new variations

*Participate in analysis activities

*Lead submissions of CMC dossiers

If you would like more details please give Akeel a call on .

Alternatively if you know someone who may be interested please pass on these details. Any referral that leads to placement is entitled to £200 vouchers.
Start date
10/2015
Duration
6 months
From
Real Staffing
Published at
03.10.2015
Project ID:
993918
Contract type
Freelance
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