Regulatory Affairs Executive - UK

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Job description

Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.

With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients' lives.

*Summary of the Position:*

We are looking for a Regulatory Affairs Executive to join our Regulatory Affairs & Technical Writing department. You will be based remotely in the UK.

You will s upport the preparation of C linical T rial applications of new and established medical products and devices , ensuring that applications are in accordance with the latest ICH guidelines and clinical trial directive s . You will be responsible for supporting the department in C linical T rial A pplication maintenance ( e.g. e TMF Filing, Regulatory tracker s etc . ).

*Key Accountabilities:*

*
* Assist in preparing early and later phase clinical trial applications to Regulatory Authorities , Ethics Committees and any other regulatory bod ies.
* Assist in preparation of Patient Information and Consent Documents , and other patient - facing documentation.
* Support R egulatory A ffairs department in maintaining awareness and compliance of current local, national, regional and harmonised guidance for regulatory and ethic al procedures and submissions.
* Support Regulatory Leads in m aintain ing specific project tracking systems incorporating all relevant information.
* Performs other duties as assigned by Regulatory Affairs & Technical Writing management team , such as eTMF Maintenance .

*Minimum Requirements:*

*Essential:*

* Basic e xperience in Regulatory Affairs and Clinical Trial s
* Demonstrates an understanding of ICH-GC
* Excellent command of the English language (written and oral) as well as a local language where applicable

*Desirable:*

* Bachelor's degree within Science or medical field or Advanced degree (Masters, PhD) or equivalent
* Experience in submitting clinical trial applications to Regulatory Authorities and Ethics Committees
* Experience with the EU Directive and National Regulatory r equirements for clinical trials
* Analytical, planning and problem-solving skills
* Fluent in another European language

Simbec-Orion Job Profile - Regulatory Affairs Executive.pdf

* Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. *