• 招聘类型:社招
  • 工作性质:全职
  • 直属部门:Regulatory
  • 所属区域:北京CBD

职位描述

Provides high level strategic and operational regulatory direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions.

  • Uses extensive knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.
  • Manages the preparation and submission of documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met.
  • Reviews sections of IND/CTA/CTN, BLA/NDA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.
  • Liaises and negotiates with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of product and labeling changes.
  • Maintains awareness of global regulatory environment and assesses impact of changes on business and product development programs. Facilitates policy and development of standard interpretation of global regulation.
  • Integrates functional expertise with business knowledge to solve problems and makes good decisions for the overall business.
  • Trains, develops, and manages direct reporting line.
  • Manages critical issues, taking leadership for the regulatory contribution.
  • Responsible for assisting with the development and implementation of regulatory processes.
  • Recruits, develops, manages and mentors regulatory professionals and helps create a goal oriented culture.

任职条件

Competencies:

Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.

Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.

Project Management - Communicates changes and progress; Completes projects on time and budget.

Computer Skills:

  • Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)

Other Qualifications:

Travel:

  • Must be willing to travel approximately 10-20%
  • Ability to work on a computer for extended periods of time

职位要求

  • 学历要求:无
  • 工作经验:无
  • 外语要求:不需要

Apply job
Balloonciaga balloonciaga To advertise your business in this spot, click here

Job Location

Share This Job