Regulatory Affairs Professional with Strong Product Registration Expertise
1 month ago
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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