Description
PROFILEA 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
This role offers an opportunity to work within one of the fastest growing pharmaceutical companies in the area and will offer endless opportunities for career development. Salary is competitive dependant on experience. For further information please email an up to date CV to Latifah Khan or call for further details.