RA Consultant - Publishing
Our client is looking to hire a Regulatory Affairs Consultant for to be based in Swindon, UK. This is a global pharmaceutical company who are involved in the acquisition and licensing of mature products. This organisation is also involved in the manufacturing and logistics of these products.
The Regulatory Affairs Consultant will be responsible for building regulatory submissions in accordance with applicable regulatory agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). The role requires guidance from direct manager and provides support and backup to management as needed.
- Performs submission build activities, including, but not limited to, ensuring submissions are built with submission-ready documents, creating inter-document links, QCing and validating compiled submissions, and submitting by target date
- Generally supports INDs, IND amendments, BLAs, BLA supplements, CTAs, MAAs, and/or MAA variations
- Provides guidance to multidisciplinary teams on developing submission structure strategies in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications
- Collaborates with vendors who support Regulatory submission related tasks
- May support document formatting, publishing, and archive activities as needed
- Identifies and communicates regulatory system enhancement needs or technical issues
- Requires knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
- Requires eCTD knowledge
- Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills
- Advanced knowledge of Microsoft Office suite, Adobe Acrobat, ISIToolbox and/or A-Pulse, electronic document management systems (SharePoint preferred), eCTD publishing systems (eCTDManager preferred), eCTD validation and viewing tools, and XML are required. Working knowledge of eCTD authoring templates (StartingPoint) is preferred
- Proven experience in industry, with relevant experience in a Regulatory Operations role
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Latifah Khan on 0203 8234 367 or upload your CV on our website www.proclinical.com. A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.