Regulatory Affairs Manager

Parexel International Corporation

Beijing, Beijing Municipality, China

A Regulatory Affairs Manager must have an understanding of the organization’s consulting models and methodologies, as well as, good knowledge of what services Parexel Regulatory and Access provides. A Regulatory Affairs Manager must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. A Regulatory Affairs Manager ensures the timely performance of work within a project scope to the quality expectations of Parexel Regulatory & Access and the client. When serving as a RAL (Regulatory Affairs Leader) or Work Stream Lead, a Regulatory Affairs Manager assures the work of the entire team or work stream is delivered on time and that it meets client’s and Parexel Regulatory & Access’s quality expectations.Qualifications+6 years experience in RA. Independent experience for China new drug registration, including HA meeting, CTA/NDA filing, post-approval activities etc.

• Project management knowledge

• Client-focused approach to work

• Results orientation

• Teamwork and collaboration skills

• Consulting skills

• Excellent interpersonal and intercultural communication skills, both written and verbal

• Critical thinking and problem-solving skills

• Proficiency in local language and extensive working knowledge of the English language

2022-08-02 00:05:13

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