Associate Director, Regulatory Affairs Marketed Products

Title: Associate Director, Regulatory Affairs Marketed Products 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, 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. The incumbent will be responsible for supporting the regulatory strategy for assigned marketed products in close cooperation with respective therapeutic area heads, pharmaceutical operations, medical, PV and marketing personnel. The incumbent will represent Global Regulatory Affairs on assigned Global Project Teams and/or Brand Teams. Major responsibilities include:

Ensures adherence to regulatory guidelines and legal requirements for Marketed Products. Ensures adequate surveillance of the regulatory environment related to assigned Marketed Products and influences and anticipates changes in the global environment. Ensures early identification and coordination of major regulatory issues relating to clinical, technical, strategic or operational information impacting successful regulatory activities for assigned marketed products (e.g. variations / line extensions). Identifies corrective regulatory measures and implements necessary corrective actions to support Global Product Development goals and timelines. Responsible for achieving assigned global regulatory affairs project objectives. Leads the Regulatory Core Team for assigned projects as it pertains to support of marketed products. Responsible for the maintenance of the regulatory core documentation for marketed products. This includes all regulatory documents needed to support maintenance of marketing authorizations (NDAs) for assigned projects in line with current quality requirements, guidelines and priorities. This also includes maintenance of labeling in support of the company's CCDS harmonization initiative. Provides the necessary regulatory input and support for PSUR compilation and submission. The incumbent will also be responsible for maintaining submission compliance as it relates to the compilation, review and coordination of necessary annual report documentation in support of Bayer's approved NDAs. In addition, the incumbent will provide necessary line management/mentoring of less experienced/newcomers in RA Marketed Products. Responsible for the maintenance of required databases for tracking and planning purposes.

Ph.D., Pharm D, or MD in life sciences with at least 3 years of pharmaceutical industry experience, (preferably within a regulatory function); or MS degree in life sciences with at least 5 years pharmaceutical industry within a regulatory function; or BS degree in life sciences with at least 7 years industry experience within a regulatory function.

Professionalism is essential, as the job holder has to work directly with different hierarchical levels within Bayer. The ability to establish and maintain effective intra- and inter- departmental working relationships is an essential requirement. Requires scientific and technical expertise, including the ability to develop robust regulatory timelines and action plans for technical submissions. Knowledge of drug regulations and applicable guidance documents pertaining to drug development and product maintenance in all main countries (with emphasis on the US) is required. The ability to work within a global team framework and a multicultural environment is required. He/she must have well developed project management skills, including good interpersonal skills. Good communication skills, both verbal and written, are imperative. He/she must be focused and target-oriented in a complex scientific / technical environment. The incumbent will be required to 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 restraints. Analytical regulatory skills are necessary. The incumbent should possess the ability to identify potential regulatory issues and to put in place the necessary corrective actions to ensure the complete and timely submission of projects under their responsibility. Experience in working with eCTD submission formats is highly desirable. Ability to work in English is required; German an advantage. 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 pharmajobs.bayerhealthcare.com. EOE/AA/M/F/D/V

Please refer to job code bayerpharm-01085 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