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At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

 

Sr. RA Manager 

 

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.


WHO YOU ARE

 

  • Education and experience:
  • Advanced technical degree (Ph.D.,  D.V.M. or Pharm.D. in life sciences with 8 years of regulatory experience or . MS with 10 years of regulatory experience or . BS with 12 years of regulatory experience
  • 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 covering all phases of drug development
  • 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

If your background and personal experience fit this profile, please send us your complete application at www.career.bayer.cn If you have any recommendations, please kindly send mail to cnreferral@bayer.com
 

 

Location:                   

China : BeiJing : BeiJing 

 

Division:

Pharmaceuticals 

 

Reference Code:

484208 


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