China RA Head

An international biotechnology company is looking to recruit an RA Head to their office in Shanghai. The organisation specialises in maximising the development and commercialisation of enabling products and technology from oncology in the greater China markets.

Job Responsibilities:

• Assist to develop and implement regulatory strategies.
• Provide regulatory advices and risk assessments on products to regulatory affairs director.
• Make regulatory plans and ensure fast registration approval, in line with regulatory requirements and China business objectives.
• Achieve successful submissions for pipeline products to regulatory authorities.
• Manage whole regulatory submissions process including dossier preparation with high quality, timely responses to deficiency questions and efficiently resolve technical issues from QC test for all applications within planned timelines.
• Work closely and swiftly with functional department to update status of regulatory projects and share solutions for potential issues.
• Provide competitors registration status to functional department.
• Intelligence: monitor and forecast regulatory environment and intelligence news periodically, and assess impact to company business, if any critical news, alert team timely.
• Lead team discussion on critical regulation/guidance.

Skills and Requirements:

• Demonstrable experience in a similar role or capacity.
• University degree preferred.
• 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 Stephen Qin at +86 21 51694107 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.

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