Regulatory Affairs Publisher

A vacancy has arisen for a Regulatory Affairs Publisher with an internationally renowned biotechnology company, based in their office in the UK. The organisation is known for their work discovering, inventing, and developing biopharmaceutical medicines in relation to science, manufacturing, and commercialisation. This vacancy is an exciting opportunity to work in a start-up environment with a company that has been consistently ranked as a 'Top Employer' in pharmaceutical and biotechnology companies.

Job Responsibilities:

• Electronically format and publish electronic documents.
• Build Regulatory submission deliverables and ensure quality, accuracy, and submission-readiness per Regulatory agency guidance and specifications and internal procedures.
• Provide guidance on good documentation and submission practices.
• Assist with developing and maintaining Regulatory document processing and Regulatory submission publishing standards and procedures.
• Identify and communicate regulatory system enhancement needs or technical issues.
• Assist with regulatory inspection activities.
• Collaborate with vendors who support Regulatory operations related tasks.
• Communicate the need for additional resources to management as needed.
• Provide support and backup to management as needed.

Skills and Requirements:

• Bachelor's Degree.
• 5-7 years in a similar or relevant capacity.
• Strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
• Advanced knowledge of Microsoft Word, Adobe Acrobat, and electronic document management systems, document authoring templates, document publishing tools, publishing systems, and eCTD validation and viewing tools.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.

• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

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 contact Roberto Esposito at +44 203 761 5702 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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