Senior Regulatory Officer required for leading pharmaceutical company.
Our client, a leading pharmaceutical company, are currently looking for a Senior Regulatory Officer to join their team. Working as a Senior Regulatory Officer you will have a good understanding of current regulatory requirements including directive and the associated legislation, notice to applicants, guidelines, and national requirements. The main responsibilities of this regulatory affairs job will include:
- Participating in the design and development of regulatory procedures and processes.
- Reviewing and commenting on draft ICH guidelines and EU QWP guidance documents as required.
- Ensuring effective communication between yourself and the senior department manager.
The successful candidate will have a strong ability to prepare, submit and respond to questions for applications submitted at various stages throughout the product lifecycle ensuring compliance with EU regulations. It is also essential that the successful candidate has the ability to:
- Critically evaluate questions raised in relation to any application within the product lifecycle and identify any buried questions and respond to these too.
- Critically evaluate any affect a change to the registered details would have on the lifecycle of a upcoming product.
- To write good quality technical documentation.
Further skills and competencies required for the role include:
- Excellent oral and written communication skills.
- Provide good quality timely advice both internally and externally.
- Communicate with regulatory authorities to help facilitate regulatory submissions/approvals.
- Have the ability to multitask.
- Prioritise and plan projects.
- Appraise management of current workloads and key issues.
If you would like to hear more about this Senior Regulatory Officer job, please contact Meera Pattni on +44 (0)1438 743047 or email email@example.com. Alternatively, to apply for this job, please click here.
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