Regulatory Affairs Senior Associate (CMC)
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Hobson Prior are working with a leading independent biotech organisation who are looking for Regulatory Affairs Senior Associate (CMC) to join them on a 12-month contract basis in Uxbridge. 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.
- Accountable to 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.
- 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.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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