Regulatory Affairs Manager / Director (US Site)

16 Jun, 2020


Regulatory Affairs Manager / Director (US Site)

Fremont, CA

We are seeking an experienced Regulatory Affairs Manager who, as a US RA team member, will contribute to the company’s regulatory affairs function and regulatory related matters for assigned projects. S/He will contribute to product development in implementing product registration (80%), as well as in providing the regulatory strategy and recommendations on project directions (20%), while in accordance with the company’s objectives. Compliant with applicable policies, procedures, and other regulations, the candidate will report to US RA head and serve as a liaison and cooperate with all functional project leads internally along with Health Authorities (HAs) externally.

Key Responsibilities:

  • Lead and provide operational direction for all regulatory affairs related submissions activities for assigned projects
  • Collect and review all regulatory submission documentation for assigned projects
  • Effectively manage assigned regulatory projects from the investigative stage through submission and approval stages and be accountable for achieving target timelines
  • Contribute to keep abreast of emerging trends and developments relating to product registration and regulatory matters US (worldwide), keeping management informed of such developments
  • Establish and maintain strong working relationships with Health Authorities (HAs) and coordinate related meetings
  • Establish strong partnerships and working relationships with functional project leads within the company
  • Participate in interest group (government, NGO, and/or industry led) events/discussions to influence relevant policy/regulation, and enhance the company image under the direction of US RA head

Experience and Qualifications:

  • 5+ years of industrial (or FDA) experience with a college degree (an advanced degree, a plus) a track record of successful drug submission and approval (or product review and regulatory project management experiences at FDA)
  • A clear track record of managing increasing levels of complexity in regulatory affairs manager roles with successful drug submissions and approvals (or product review and regulatory project management experiences at FDA)
  • Thorough knowledge and understanding of drug development regulations in China, US, and/or EU from having led the regional (or global) regulatory submission for product development
  • A successful track record of developing and maintaining relationships with the HAs
  • Experience working with multi-disciplinary teams and in all phases of drug development
  • Capable of establishing credibility within the company as well as with external partners, able to build consensus and achieve goals through influence versus direct line authority
  • Outstanding communication, negotiating, and listening skills
  • Fluent in English, proficiency in Chinese highly desirable

Learn more here

Job posted: 2020-06-16