Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

RA Manager

Your tasks and responsibilities


 • Responsible for planning and preparing license maintenance strategy.
 For new products, regulatory strategy development should be under
 direction
 • Independently responsible for regulatory activities for maintenance
 of marketed products, for new products, which should be under direction
 • Independently responsible for timely tracking and update the projects
 status, closely monitor projects progress, foresee the potential
 queries of HAs for assigned products and seek for the feedback from HAs.
 • Serve as a primary contact person with HAs for assigned
 products/projects.
 • Responsible for internal communication under supervision
 • Participate in a global regulatory team (GRT) and provided local
 regulatory input into the global development plan for assigned projects
 after alignment with the supervisor
 • Take the responsibility for DA review of the assigned products, and
 may be assigned other tasks such as SOP/OI Taskforce contribution, RA
 intelligence and competitor information etc.
 • Ensure the compliance of Company internal Policy/ system/ database/
 responsible projects and local regulation compliant behavior

 

Requirements


 Education & Experience:
 • Advanced technical degree (Ph.D.,  D.V.M. or Pharm.D.) in life
 sciences with 4 years of regulatory experience
 or
 • MS with 6 years of regulatory experience
 or
 • BS with 8 years of regulatory experience
 
 Specialised Training:
 • Drug law and registration regulation training
 • Bayer Drug Regulatory Affairs training
 • Basic GCP training
 • ICH guideline training
 • Management skill training
 
 Knowledge & Skills:
 Knowledge:
 • Basic knowledge of  local Health Authority (HA) regulations (FDA or
 EMA) to support filings
 • Basic understanding of drug development (PK, PD, statistical
 concepts, data collection, endpoints, etc.)
 • A thorough knowledge of company policies and procedures in drug
 development and product maintenance requirements
 Skill:
 • Good communication skills, verbal and written, are required
 • Ability to work within a global team framework
 • Strong analytical skills are required

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Country: China
Location: BeiJing

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Last update: Dec 4, 2018   Copyright © Bayer AG
URL: https://career.bayer.cn/opencms/opencms/job/Medical-Representative--SF31103.html