Regulatory Affairs Coordinator

Title: Regulatory Affairs Coordinator Location: NJ-Montville At Bayer HealthCare Pharmaceuticals we take pride in knowing that our work is an affirmation of life. It stems from our commitment to advance patient care and to shape the future of medicine. It also connects us to the many lives we serve in the Women's Healthcare, Oncology, Diagnostic Imaging, Hematology/Cardiovascular, Primary Care and Neurology markets. We are a global research-based pharmaceutical company and our purpose is to bring diagnostic and therapeutic innovations to the healthcare community. With a vast global network and a robust product pipeline and U.S. revenues exceeding $2.6 billion, we offer the opportunity for career fulfillment and the chance to make life the best it can be.  This position is available in the Global Regulatory Affairs department located in the Montville, NJ offices. Position Summary: In this role you will perform independently, or with only minimal supervision, more difficult/complex regulatory, technical, or administrative tasks to support the ongoing operations of the Regulatory Affairs Department. Coordinate and oversee the preparation of regulatory sections/components that are included in domestic and international submissions to ensure that they are prepared correctly, properly reviewed, and submitted with the correct forms to the appropriate division within FDA or other regulatory authority. Perform quality control checks on these submission components, as well as on corrections made to these components, and ensure compliance with Bayer Standard Operating Procedures (SOPs) and regulations. Coordinate or act as a database resource manager and trainer for departmental administrative/clerical staff. Train, allocate or check the work of other secretarial and clerical staff. Substitute for supervisor/manager at meetings. * High school graduate or equivalent with a minimum 9 years of progressively increasing administrative experience, at least 5 years of which must have been in a clinical research, regulatory, or technical environment. * BA/BS degree preferred. Hands on regulatory administrative/clerical experience including use of regulatory related databases is required. A thorough knowledge and understanding of FDA submission requirements for Investigational New Drug Applications (IND), New Drug Applications (NDA), Drug Master Files (DMF) and other related material is essential. * An understanding of the information required for foreign regulatory submissions is desirable. * Completion of a training course regarding SOPs and Federal Regulations is required. Must have an understanding of and experience in utilizing medical and technical terminology in a regulatory environment. * Must be fully cognizant of and responsive to shifting priorities and be able to interact with professional staff at all levels. * Excellent organizational and verbal/written communication skills are necessary. Independent judgment, discretion and problem solving is required. * Excellent computer skills required including a working knowledge of database management as well as proficiency in Microsoft Word, Excel and PowerPoint. As a member of the Bayer HealthCare Pharmaceuticals team, you'll find an environment that celebrates diversity and welcomes the open exchange of ideas and individual perspectives. We are proud to offer an attractive salary along with a generous benefits package designed to support the needs of you and your family while addressing work/life balance issues. To learn more about Bayer HealthCare Pharmaceuticals or to apply online, please visit our website at www.bayerjobs.com. EOE/AA/M/F/D/V

Please refer to job code bayerpharm-00859 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Montville, NJ
County:	Morris County
ZIP Code:	07045
Pay Rate:	Open
Job Terms:	full time
Company:	Bayer
Phone:	email only please
Fax:	email only please