Manager, Regulatory Affairs

Title Manager, Regulatory Affairs  Description The Manager, Regulatory Affairs, reports to the Director, Global Regulatory Affairs and is responsible for implementing regulatory strategies developed with the assistance of the Director, Global Regulatory Affairs; for actively contributing to the development and implementation of regulatory strategies for assigned projects and programs; providing regulatory support for several clinical development projects through participation on clinical development teams and preparing and filing and regulatory applications in the United States, Europe and rest of world (ROW). . Principal Responsibilities and Duties: ? Coordinate all aspects of regulatory submissions relevant to assigned projects ? Work with the Director, Global Regulatory Affairs to develop worldwide regulatory strategies, in conjunction with business objectives, and translate these plans into operational deliverables, such as submissions ? Interact with regulatory agencies regarding assigned projects, as appropriate ? Monitor, review and analyze the development of new requirements and regulations and provide input on their impact on products/projects ? Manage quality and timelines of regulatory activities and milestones ? Develop policies and procedures to ensure regulatory compliance for areas of responsibility, as needed ? Provide direction and mentoring to regulatory staff that support and complement the efforts of other functions to achieve overall corporate goals and objectives

The position is located in Corporate Headquarters in Clinton, New Jersey. Periodic domestic and international travel may be required. Position must be willing to work outside of normal business hours.

Please refer to job code ikaria-411975 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Clinton, NJ
County:	Hunterdon County
ZIP Code:	08809
Pay Rate:	Open
Job Terms:	full time
Company:	IKARIA
Phone:	email only please
Fax:	email only please