My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and is looking to recruit a Regulatory Affairs Associate on a 6 month contract based in Middlesex.
To ensure that appropriate content for specific submissions supporting Research and Development projects is developed and delivered to agreed timeframes and in compliance with company processes and policies as they apply to the role.
- Responsible for development & refinement of the CTA lifecycle strategy and implementation of submissions.
- Coordination of CTA lifecycle submissions to ensure timely delivery and ensuring the content is appropriate to each individual regulatory agency while maintaining compliance with company policy and procedures
- Accountable to the Clinical Study Support Team Manager for overall work plans.
- Accountability for agreed tasks and projects.
- Ensure independent communication, with a range of internal staff, in support achievement of the assigned goals.
- Ensure compliance with company CTA and maintenance process through timely action and completion of records in internal systems
- Ensure quality of own work to agreed timeframes, including compliance with internal systems and record keeping.
- May provide additional support to additional projects.
- Degree in any life sciences
- Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
- A good understanding of Clinical Trial Directive and CTA submission requirements for multiple countries/submission types
- Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
- Role requires a good understanding of submission requirements for multiple countries/submission types and an ability to work in a matrix environment.
If you are interested in this role or would like to have a confidential discussion regarding other Regulatory Opportunities. Please contact me: Natasha.Rollason@srgtalent.com or 01753 589673
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