職位描述
職位描述：
崗位職責(zé):
Responsibilities:
1.Under supervision, contribute to the development and implementation of global regulatory strategies for assigned projects
2.Act as a regulatory liaison to interact with the external partners, and internal-functional departments; participate in or lead project teams
3.Be responsible for managing the preparation, compilation of regulatory applications to support international, especially US and EU registration
4.Stay abreast of global competitive landscape, regulatory environment, regulations and guidance
5.Participate in International Business Development efforts, as assigned
任職資格:
Requirements:
Education –
1.Minimum Bachelor’s degree in a scientific or related disciplines, higher degree preferable (Pharm. D.; MSc, PhD)
2.Excellent spoken and written English
Professional skills and experience –
1. 5+ years of pharmaceutical industrial experience, of which 3 years in Regulatory Affairs.
2.Must have Hands-on experience in product registration in US or EU
3.Familiar with the development process for the biological products, especially biosimilar products. Prefer to have working experience in the development or manufacture in global pharmaceutical companies.
4.Must have experience in preparing IND, CTA, NDA, BLA or MA, especially for the CMC sections. Experience in preparing pre-clinical and / or clinical sections is a plus
5.Must have working knowledge of global regulations and guidance as they relate to the global regulatory strategy
6.Prefer to have experience in interactions with international health authorities, especially FDA or EMA
Personal skills and competencies -
7.Self-starter, and able to work well independently
8.Excellent written and spoken communication skills
9.Attention to details
10.Ability to work in teams
11.Strong organizational and planning skills
Graduates with overseas study experience and related background are strongly welcome.
