• Bayer AG
  • $177,070.00 -177,070.00/year*
  • Whippany , NJ
  • Executive Management
  • Full-Time

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.

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.
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Associate Director, Global Regulatory Strategy, CMC
Your tasks and responsibilities
The primary responsibilities of this role, Associate Director, Global Regulatory Strategy, CMC are to:
* Represents global RA CMC in various cross-functional teams, including CMC development teams, product supply teams, global regulatory teams;
* Responsibility for the regulatory strategy with regard to Chemistry Manufacturing and Controls (CMC) for assigned products and product portfolio in close cooperation with the relevant global, regional, and country RA functions, BHC Product Supply, Quality, Medical, and Marketing to ensure early identification of major regulatory hurdles and issues;
* Provides active input into Global Regulatory Teams for assigned projects to ensure timely submission and first cycle approval;
* Responsibility for timely availability and final CMC content of IND/IMPD, NDA/BLA/MAA, or supplemental submissions for assigned products and product portfolio to Health Authorities, including responses to health authority questions;
* Responsibility for CMC change management evaluation for assigned development and marketed products. Responsible for compiling variation packages and coordination of responses to health authority questions;
* Collaboration with CMC Managers, Senior Managers, and Specialists to ensure close alignment of CMC activities across the Therapeutic Area groups;
* Proposes and implements standards concerning CMC documentation in close co-operation with global, regional, and local RA functions, and BHC Product Supply;
* Responsibility for achieving assigned global regulatory affairs project objectives for assigned products and product portfolio using effective oral, written, and presentation skills. The ability to deal with critical and/or sensitive issues with internal and external customer groups will be required;
* Ensures adequate surveillance of the CMC related regulatory environment, particularly for assigned biotechnology and pharmaceutical products, and anticipates and influences changes in this environment globally.
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:
* Advanced technical degree Ph.D., DVM or Pharm D in life sciences preferred 6 years in medical research activities of which 1-3 years include local/ global regulatory experience, or MS degree with 8 years of medical research activities of which 3-5 years include local/global regulatory experience, or BS degree with 10 years of medical research activities of which 5-10 years include local/global regulatory experience;
* Excellent oral and written communication skills;
* Ability to work within a global team framework and a multi-cultural environment;
* Ability to focus on multiple issues at one time, and to organize and direct diverse activities in a changing environment often under time pressure;
* Incumbent must have good knowledge of the pharmaceutical industry, general business practices and processes;
* Goods problem-solving skills as applicable to drug regulatory issues, and preferably experience in dealing with Drug Regulatory Bodies;
* Strong analytical skills and well-developed project management skills;
* The position requires scientific and technical expertise, including the ability to develop/execute robust regulatory strategies, timelines and action plans.
Preferred Qualifications:
* Knowledge of biotech and/or gene therapy development is a plus;
* Knowledge of drug regulations and guidance documents on drug development and license variations in ICH countries is preferred;
* Knowledge of regulatory expectations in non-ICH regions is desirable.
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.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
Country: United States
Location: NJ-Whippany
Functional Area: [sap_fa_32]
Entry Level: 5
__________________________________________________
__________________________________________________
Apply online

* Advanced technical degree Ph.D., DVM or Pharm D in life sciences preferred 6 years in medical research activities of which 1-3 years include local/ global regulatory experience, or MS degree with 8 years of medical research activities of which 3-5 years include local/global regulatory experience, or BS degree with 10 years of medical research activities of which 5-10 years include local/global regulatory experience; * Excellent oral and written communication skills; * Ability to work within a global team framework and a multi-cultural environment; * Ability to focus on multiple issues at one time, and to organize and direct diverse activities in a changing environment often under time pressure; * Incumbent must have good knowledge of the pharmaceutical industry, general business practices and processes; * Goods problem-solving skills as applicable to drug regulatory issues, and preferably experience in dealing with Drug Regulatory Bodies; * Strong analytical skills and well-developed project management skills; * The position requires scientific and technical expertise, including the ability to develop/execute robust regulatory strategies, timelines and action plans. Preferred Qualifications: * Knowledge of biotech and/or gene therapy development is a plus; * Knowledge of drug regulations and guidance documents on drug development and license variations in ICH countries is preferred; * Knowledge of regulatory expectations in non-ICH regions is desirable.

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. Bayer is an Equal Opportunity Employer/Disabled/Veterans Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.


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* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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