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ETeam Inc
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Cambridge, Cambridgeshire
Senior Associate Regulatory Affairs
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Salary: £23 per hour |
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Overview
Job Title: Regulatory Affairs Associate Job Duration: 12 Months Job Location: Uxbridge / Cambridge Hours per Week: 37.5 Hours The Regulatory Professional under the direction of a Regional Regulatory Lead will lead compilation of CMC regulatory packages for submission and may be the lead for a program under supervision. Collect and / or create country specific documents for regulatory filings worldwide. Compile and maintain CTA/MA documentation (e.g. variations, substantial amendments) in collaboration with Regional Regulatory Lead. Ensure compliance via timely submissions to regulatory agencies. Coordinate collection of functional documents in support of regulatory applications. As appropriate support execution of regulatory strategy. Support process improvement initiatives, standards development, and metrics. Assist in template development and maintenance. Train and supervise junior staff. Key Skills: Strong communication skills - oral and written; Ability to multi-task in a fast paced environment; Organizational skills; Understanding of drug development process; knowledge and understanding of CMC requirements, especially country specific documents for international filings; Familiarity with Document Management Systems.