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.

Sr. RA Manager - CMC

Your tasks and responsibilities


 • Responsible for planning and preparing the regulatory CMC strategy for assigned  projects (both marketed and new products)
 • Independently responsible for regulatory activities and CMC strategy implementation for assigned  projects (both marketed and new products)
  • Early identify potential CMC risks and propose the solutions for assigned projects and be able to influence the HAs' decisions.
 • Serve as a primary contact person with HAs for assigned products/projects CMC technical reviewing.
 • Build a good working relationship with HAs and academic association
 • Responsible for internal communication for assigned products/projects and represents China RA CMC position and influence by given insight and technical input to drive achievable results, including both local quality, supply chain and global functions
 • Manage people to take the responsibility for the assigned projects and give guidance to subordinates if applicable

• Ensure the compliance of Company internal Policy/ system/ database/ responsible projects and local regulation compliant behavior/sub-group.
 Should be able to foresee potential risks of compliance, especially from CMC perspective.


 Position: Skills,...


 I. Education:
 • Advanced technical degree (Ph.D.,  D.V.M. or Pharm.D. in life sciences with 6 years of regulatory experience
 or
 • MS with 8 years of regulatory experience
 or
 • BS with 10 years of regulatory experience
 
 II. Knowledge:
 • In-depth knowledge of regional HA regulations to support filings. Some familiarity with global regulations.
 • Knowledge and experience in drug development (manufacture, quality control, analytical, CTD, ICH guideline, GMP, QBD, etc.)
 • A thorough knowledge of company policies and procedures in drug development and product maintenance requirements
 • The position requires scientific and technical expertise, including the ability to develop robust CMC regulatory plans coveringall phases of drug development
 
 III. Skill:
 • Excellent communication skills, verbal and written, are required
 • Demonstrated ability to influence in a team environment
 • The ability to work within a global team framework and a multi-cultural environment is required
 • Strong analytical skills are required
 • Demonstrated leadership and project management skills, including cross-functional communication, interpersonal and influence-management skills
 • Must have the ability to organize and direct diverse activities in a changing environment often under time pressure.
 • Demonstrated problem solving as applied to local regulatory issues

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
Functional Area:
Entry Level: