eNewsletter Signup
Miles
Km80.5

Associate Director, Chemistry Manufacturing and Control

Bayer Business and Technology Services LLC

E-Mail to a Friend Add to Job Folder View All Jobs Back to Search Results Share
Location: Berkeley, CA Posted Date: 4/10/2013 Position Type: Full time Job Code: 0000048947 Required Education: Doctorate/PhD

Description

Bayer HealthCare (BHC) makes an important contribution to human and animal health with its innovative products and by researching new therapeutic approaches promoting science for a better life throughout everything that we do. Our Specialty Pharmaceutical business ranks among the top 10 specialty pharmaceutical companies worldwide. Our global research and
development is focused in five distinct areas: Diagnostic Imaging, Hematology/Cardiology,Oncology, Specialized Therapeutics, and Women's Healthcare. As a specialty pharmaceuticals company, we focus our efforts in areas of high unmet medical need and where we can have the most impact. Our Medical Care division consists of Diabetes Care and Radiology and Interventional. The Diabetes Care division is one of the largest blood glucose monitoring businesses in the world, supporting customers in 100 countries. Radiology and Interventional is the world's leading supplier of contrast agents and injection systems for diagnostic and therapeutic medical procedures. The business also supplies mechanical systems for removing thrombi from blood vessels. Our Consumer Care business is a top
competitor in many important product categories including analgesics,cough and cold, and nutritionals. More than 3,000 employees support 14 manufacturing sites in 11 countries dedicated to ensuring the delivery of a secure, high-quality, cost-effective supply of our products around the world. Our Animal Health business in North America is dedicated to
making the world a better place for our veterinary customers,their clients, and the animals we all hold dear.

Responsible for 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.
• Represents RA in CMC development teams and RCTs for assigned projects
• Close alignment of CMC manager with all TA’s
• Responsible of the final content of Health Authority CMC product submissions for assigned products.
• 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.
• Proposes and implements standards concerning CMC documentation in close co-operation 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).
• Makes 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 achieving assigned global regulatory affairs project objectives.

Requirements

Requires Ph.D., Pharm D, or MD in life sciences with 8 years industry experience of which 3 years include FDA and/or EMA regulatory experience. Or MS degree in life sciences with 10 years industry experience or BS degree in life sciences with 12 years industry experience of which 5 years include FDA / EMA regulatory experience.
• Relevant regulatory experience with Biologics / Biotech products would be an advantage.
• Complete knowledge of, and expertise in interpretation of, the FD & C Act, FDA Code of Federal Regulations and Prescription Drug Marketing Act especially for advertising,promotion, labeling, sample distribution, and scientific & educational activities is essential.
Also essential is the in depth knowledge if relevant ICH guidelines and relevant guidelines as well as legal requirements from other major regions of the world.
• In-depth experience in pharmaceutical and/or Bio-pharmaceutical business with knowledge of existing product line is desirable.
• Extensive experience and excellent interpersonal skills are required as the incumbent must be able to knowledgeably discuss, negotiate, and effectively deal with manufacturing and legal product concerns and regulatory issues pertaining to CMC (and advertising and promotion and other labeling, as applicable).
• Effective oral and written communication skills are critical to deal professionally with sensitive issues involving Bayer, and FDA staff at various levels concerning CMC activities, promotional activities, as applicable.
• Competence to provide regulatory decisions and direction to marketing, quality and other functions / departments regarding strategy for CMC including timelines and risks (advertising and promotional activities as applicable) is a must, including ways to diffuse competition,as applicable.
• The incumbent should have thorough knowledge of the pharmaceutical and/or
Bio-pharmaceutical industry, the company’s strategic marketing needs, business practices and processes.
• The position requires scientific and technical expertise, including the ability to develop robust regulatory timelines and action plans covering technical and labeling variations (as applicable) as well as line extensions. Knowledge of drug regulations and guidance documents on
variations/ drug development in all main countries is required.
• Preferably, Incumbent has a thorough knowledge of company policies and procedures in drug development and maintenance, preferably relating to Biotech products and product development.

To be considered for this position please apply to the direct link below :
https://mybayerjob.bayerbbs.com/sap/bc/webdynpro/sap/hrrcf_a_posting_apply?param=cG9zdF9pbnN0X2d1aWQ9MDA1MDU2ODkwMEI0MUVEMjk3ODU4MUIzRDk4MDU3NjYmY2FuZF90eXBlPUVYVA%3d%3d&sap-client=005&sap-language=EN¶ms=cG9zdF9pbnN0X2d1aWQ9MDA1MDU2ODkwMEI0MUVEMjk3ODU4MUIzRDk4MDU3NjY%3d
E-Mail to a Friend Add to Job Folder



By applying to/saving a job using , you are agreeing to comply with and be subject to the Terms of Use for use of our website. To use our website, you must agree with the Terms of Use and both meet and comply with their provisions.

ADVERTISEMENTS