職位描述
職位描述：
崗位職責:
Responsibilities:
1.Under guidance of Sr. Regulatory staff, 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 project teams
3.Be responsible for managing the preparation, compilation of CMC sections for regulatory applications to support international, especially US and EU registration
4.Stay abreast of global competitive landscape, regulatory environment, regulations and guidance
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. 3+ years of pharmaceutical industrial experience, of which 0 - 1 year in Regulatory Affairs.
2.Familiar with the development process for the biological products, especially biosimilar products. Prefer to have working experience in product development or aseptic manufacture process in global pharmaceutical companies.
3.Prefer to have experience in preparing IND, CTA, NDA, BLA or MA, especially for the CMC sections.
Personal skills and competencies -
1.Self-starter, and able to work well independently
2.Excellent written and spoken communication skills
3.Attention to details
4.Ability to work in teams
5.Strong organizational and planning skills
Graduates with overseas study experience and related background are strongly welcome.
