Description
Regulatory Affairs OfficerGloucestershire
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