RA Manager

A leading bio-pharmaceutical company is partnering with Proclinical to recruit an RA Manager to join their office in Beijing. The organisation accelerates the development and commercialisation of speciality healthcare products for serious and critical medical conditions in China, Korea, and Taiwan. This is an exciting opportunity to work with a highly-seasoned team that has extensive Chinese drug development experience.

Job Responsibilities:

• RA Project Planning and executions.
• Preparing IND and NDA dossier through coordination with other R&D colleagues or external CMO/CRO consultants.

• Undertaking function operation responsibilities.
• Fully accountable for registration project handling independently, including marketed products and development projects

Skills and Requirements:

• 5 years working experience on drug regulatory affairs in pharmaceutical companies, especially experienced on earlier development, dossier preparation, provincial, and central NMPA communications
• Capable for project registration plan setting up and implementation
• Experienced about cross-function discussion with local and Global development team about regulatory strategy discussion and project planning
• Skilled in HA communications.
• Experience in handing GMP inspection, expert panel meeting.
• Good English for being accountable for communications with Global team for project issues, as well as regulations and registration process.
• Experience in big molecule development.
• Experience in handling FDA submission.
• Experience in RA internal SOP development.
• Chinese speaker only
• Demonstrable project management skills.
• 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 Kirsty Zhuang at k.zhuang@Proclinical.com 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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