Regulatory Affairs Professional with Strong Product Registration Expertise

1 month ago


Beijing, Beijing, China Bayer Full time

About Bayer

We're a leading life science company driven to solve the world's toughest challenges and make a positive impact on people's lives.

Role Overview

As an Associate RA Manager, you will play a critical role in our regulatory affairs team, overseeing the registration process for new products and ensuring compliance with local regulations.

Key Responsibilities:

  • Develop and execute registration strategies for new products, including project planning and coordination with cross-functional teams.
  • Lead the registration process for new products, ensuring timely completion and adherence to regulatory requirements.
  • Manage regulatory activities for maintenance of marketed products, including monitoring project progress and keeping stakeholders informed.
  • Closely monitor projects' progress and keep the project timeline. Prepare HA submission dossier. Feedback test lab, HA and other stakeholders timely.
  • May be assigned other tasks such as SOP/OI Taskforce contribution, RA intelligence and competitor information etc.
  • Review and approve Chinese labeling.
  • Ensure the compliance of Company internal Policy/ system/ database/ responsible projects and local regulation compliant behavior.
  • Communicate the project dashboards of responsible pre market submission projects with key stakeholders and management team.
  • Facilitate the type testing activities, tracking and resolve the open issues with engineering team in timely manner and obtain the reports without post market compliance risks.
  • Conduct assessment and gap analysis for new standards and regulations.
  • Conduct regulatory assessment of design changes without compliance issue.
  • Other tasks assigned by management.

Requirements:

  • Advanced technical degree in Electrical Engineering or Bio medical Engineering or BS with above 5 years of regulatory experience.
  • Excellent knowledge of NMPA Regulations on medical device administration.
  • Working knowledge of medical device development and product maintenance requirements.
  • Excellent written and verbal communication skills and proficiency in English.
  • Demonstrated planning and organizing, customer focus, and cross functional/teamwork skills.

Salary Range:

The estimated salary for this role is between $120,000 - $180,000 per annum, depending on location and experience.



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