Manager Chemistry Manufacturing and Control (CMC) in Whippany, New Jersey | DiversityInc Careers
 
This job has expired and you can't apply for it anymore. Start a new search.

Manager Chemistry Manufacturing and Control (CMC)

.pre {white-space: pre-wrap;} Your tasks and responsibilities

 

The primary responsibilities of this role, Manager Chemistry Manufacturing and Control (CMC), are to: 

 

  • Responsible for assisting with the regulatory strategy for Chemistry Manufacturing and Control (CMC) for assigned products in close cooperation with country or regional RA with the Health Authorities, and with BHC Product Supply, Global CMC, Medical, Drug Safety and Marketing;

  • Close alignment of CMC manager with all TA’s;

  • Responsible for the coordinated implementation of CMC changes after HA approvals with product supply;

  • Ensure early identification and coordination of major regulatory issues to regulatory guidelines and legal requirements for CMC;

  • Propose and implement standards concerning CMC documentation in close cooperation with BHC Product Supply and Global CMC;

  • Responsible for the change management for product development, tracking of CMC changes and processing requests or related documentation (evaluation, consolidation, prioritization and review);

  • Make sure that adequate surveillance of the regulatory environment related to CMC has been put in place and influences and anticipates changes in this environment globally;

  • Responsible for archiving assigned global regulatory affairs project objectives.

 

.pre {white-space: pre-wrap;} Who you are

 

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

 

Required Qualifications:

 

  • Bachelor's Degree with four (4) years of experience in biomedical activities; or Master's Degree with one (1) year of experience in biomedical research activities; or Advanced technical degree (Ph.D., D.V.M. or Pharm.D.) in life sciences with none or limited (less than one year) regulatory experience;

  • Must have a good understanding of the drug development process and FDA regulations that govern it;

  • Scientific and technical understanding which includes the ability to develop robust regulatory timelines and action plans involving technical issues;

  • Knowledge of drug regulations and guidance documents on variations/drug development in all main countries is preferred;

  • Participation in the company’s strategic marketing needs, business practices and processes;

  • Ability to work focused and target oriented in a complex scientific / technical environment, focus on multiple issues at one time, and must have the ability to organize and direct diverse activities in a changing environment often under time pressure. In many cases competing objectives will have to be harmonized and reconciled to achieve the overall objectives;

  • Ability to work within a global team framework and a multi-cultural environment is essential. He/she must have well developed project management skills, including interpersonal skills. Good communication skills, verbal and written, are required;

  • Professionalism is essential, as the job holder has to work directly with different hierarchical levels within BSP, as well as the ability to establish relationships between individual departments;

  • Must process information efficiently and effectively.

.pre {white-space: pre-wrap;} 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.