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RA Head

Job Title: RA Head
Contract Type: Permanent
Location: Shanghai, China
Industry:
Salary: Negotiable
Reference: 20200705_1579502337
Contact Name: Cherry Zhu
Contact Email: czhu@profileasia.com
Job Published: January 20, 2020 14:39

Job Description

Job Responsibilities

  • Assist to develop and implement regulatory strategies.
  • Provide regulatory advice and risk assessments on products to RA Team.
  • Make regulatory plans and ensure fast registration approval, in line with regulatory requirements and China business objectives.
  • Achieve successful submissions for pipeline products to regulatory authorities.
  • Manage whole regulatory submissions process including dossier preparation with high quality, timely responses to deficiency questions and efficiently resolve technical issues from QC test for all applications within planned timelines.
  • Work closely and swiftly with the functional department to update the status of regulatory projects and share solutions for potential issues.
  • Provide competitors registration status to functional department.
  • Intelligence: monitor and forecast regulatory environment and intelligence news periodically, and assess impact to company business, if any critical news, alert team timely.
  • Lead team discussion on critical regulation/guidance.

 

Skills And Requirements

  • Demonstrable experience in a similar role or capacity.
  • University degree preferred.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organizational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

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