JOB DESCRIPTION

 

JOB FUNCTION:      Regulatory Affairs

GRADE/TITLE:         Director/Senior Director

EMPLOYER:             Brii Biosciences (腾盛博药)

DEPARTMENT:       Clinical Development

JOB LOCATION:     Beijing, China

REPORTS TO:         CMO

SUMMARY:            Provide global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of pipeline products

 

DUTIES AND RESPONSIBILITIES:


  • Development and execution of therapeutic area regulatory product strategies and plan including precedence, gap analysis, risk management, and contingency planning

  • Develop key documents for regulatory submissions

  • Participate and represent Regulatory Affairs on Product Development Team, providing expert regulatory strategy and regulatory decision making

  • Mentor and lead junior team members

  • Oversee external vendors in translation, QC/QA, assembly and publication of regulatory submission package

  • Contribute to the target product label, core data sheet, and labelling for relevant products

  • Monitor, assess and communicate to staff impact of relevant global regulations, guidance, and current regulatory environment

  • Responsible for Health Authority interactions within assigned area

  • Participate and represent Brii Biosciences on external partnership committees

  • Participate in licensing/acquisition due diligence and other activities

 

QUALIFICATIONS:


  • Master or PhD degree with 10-year of experience in regulatory affairs or relevant area

  • Good understanding of relevant regulatory guidelines, GxP, and clinical development process in the pharmaceutical industry

  • Recent regulatory experience in product development including CTA/IND and NDA/BLA, extensive experience with late stage development/marketed products, and in-China experience is required

  • Direct interaction/negotiation with regulatory authorities

  • Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance

  • Excellent written and verbal communication skills in Chinese and English. Ability to explain regulatory requirements to development team members and co-development partners in a simple and effective fashion

  • Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions

  • Excellent operational skills including planning, organizing and ability to motivate and lead others

  • Good people leadership skills and people management experience is strongly preferred


The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.