Careers

RA Manager

Responsibilities:

  • Initiate, track and facilitate new product registrations in US and achieve on-time approvals;
  • Monitor regulatory environment changes and provide impact analysis plus action plans to ensure compliance;
  • Interact with local regulatory authorities, experts and industry groups to drive new guidelines and regulations towards harmonized international standards;
  • Give regulation guidance to research, development, manufacture and clinical team to push forward the progress of the project.
  • Communicate with FDA or other authority group as representative of company.
  • Report to RA director in China and assistant to communicate with US team and support registration in China.

Qualifications:

  • Bachelor’s degree or above in Pharmaceutical related discipline;
  • Minimum 5 years’ experience in biopharmaceutical industry and minimum 3 years’ experience in RA function;
  • Sound insight of the regulatory requirement with good networking and relationship with FDA;
  • Strong interpersonal skills include negotiation skills and significant experience in interacting with regulatory authorities;
  • A team player with good communication and influencing skills; Ability to lead, coach, and motivate others.

If interested in this position, contact us at careers@fronteratherapeutics.com