Careers

Regulatory Affairs Specialist
Shanghai based

Our Regulatory Affairs team is gearing up for an exciting 2019 and 2020, with major product submissions across our pipelines in development. In the role of Regulatory Affairs Project Associate, you will prepare and execute regulatory submission planning and implement agreed regulatory strategy to register our pipelines in development in China. You will demonstrate knowledge of regulatory affairs submissions and contribute to business improvement and compliance activities within the Regulatory Affairs Department.

The role is an opportunity for you who would be keen to move into a biopharmaceutical company broadening job scope in order to develop further in career.

Competencies:

  1. Regulatory knowledge
    -Understands China (CDE/ CFDA) regulations, local guidelines & evolving
    environment and applies to the work
    following CFDA regulations
  2. Drug Development and Business Knowledge
    -Understands key activities in drug development and commercialization, the role of different function areas and incorporates into regulatory activities
    -Understands UBP business principles and incorporates into regulatory decision-making process
    -Understands pre-clinical, clinical and manufacturing drug development knowledge and applies to regulatory activities
  3. Stakeholder management
    -Understands the structure, key roles and responsibilities of internal and external stakeholders (regulatory associations and authorities)-Builds relationships internally and externally, and applies effective stakeholder management practices
  4. Change management
    -Accepts change as positive
    -Adapts to changing conditions
    -Departs from accepted group norms of thinking and behaving when necessary

 

Responsibilities:

-Participate as a member of local cross-functional teams, providing regulatory input to the development plans
-Meets timelines for completing regulatory filing/approval and other activities with desired quality
-Identify potential regulatory risks to defined strategies and operational plans and contribute to proposals to mitigate risks
-Conduct all activities and interactions consistent with UBP values and in compliance with Code of Ethics, UBP policies and procedures

Requirements:

B.S. or above in Pharmacy, Medical, Biology or related field

Relevant working experience:

* > 2 years’ experience in MNC or local Pharma company, at least 6 years in Regulatory
* independent working
* experience in drug/biologic manufacturing is a plus

Language and PC Skills:

Chinese (mother-tone level) and English (proficiency level)
Computer skill: word, excel, power-point