Initially 6 months contract - potentially ongoing
Attractive hourly rate
This role will support the Business in the development, commercialisation and lifecycle management of products for customers on a global basis. This will include membership of development or commercialisation teams providing regulatory advice on product development and maintenance issues. Preparation of regulatory documentation including IMPDs, Drug Master Files and CTD documents and responsibility for estimation and monitoring of regulatory resource requirements.
- Participation in technical reviews of data
- Preparation, review and submission of regulatory documentation.
- Preparation of regulatory presentations (as required).
- Responding to regulatory questions from technical teams.
- Reviewing specifications for drug product, CCS and excipients.
- Reviewing CMRs related to drug product, CCS and excipients.
- Reporting of product and project issues or delays to management.
- Communicating learning for continuous improvement.
- Communicating change proposals to customer and agreeing course of action.
- Monitoring developing and evolving global regulatory guidelines which impact the development and maintenance of products.
- Providing assessment of the implications of the proposed legislation to the development and or marketed product support teams with recommendations for courses of action.
- Graduate degree (B.Sc. or similar) in pharmacy or a life science or other scientific-based qualifications plus industry experience and knowledge.
- Significant years of regulatory experience within the pharmaceutical industry.
- Detailed Knowledge of European Regulatory Affairs environment - Guidelines & Legislation.
- Experience of the Pharmceutical industry including: drug development, pharmaceutical R&D and manufacturing processes.
- Able to coach and mentor other staff.
If you're interested in the role please apply online, alternatively call me on 0121 728 8455 if you have any questions.
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