Regulatory Affairs Officer

Job type:
permanent
Start:
08/2015
Duration:
n.a
From:
Real Staffing
Place:
Gloucestershire
Date:
08/19/2015
Country:
flag_no United Kingdom

Project description:
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Regulatory Affairs Officer

Gloucestershire

Up to £35,000

I am looking for a highly efficient, quick learner and enthusiastic regulatory professional experience in regulatory affairs, quality assurance, and quality control. Possessing a good understanding of the essential requirements of regulatory compliance. Knowledge of CMC module in generic products. Proven experience of projects handling and completion on timely manner.

KEY SKILLS
  • Prepare and submit variations from type 1A's to type II's
  • Writing and updating SOPs
  • Author, amend and review module 3 documents of dossier
  • Product Registration, Renewals and Variation application submissions in UK and Export markets
  • Sound knowledge of Global Regulatory Guidelines and cGMP standards
  • Experience in dealing with MHRA and other competent authorities
  • Ability to maintain relationships with third party regulatory counterparts


If this is something you would consider then please do give me a call on Alternatively email me on L.khan(a)realstaffing.com

Looking forward to hearing back from you with feedback or referrals.

Kind regards,

Latifah Khan