Regulatory Affairs Assoc III

Job Title Regulatory Affairs Assoc III AutoReqId 6796BR Location Morristown, NJ Department RegAffairs-Gen Job Description

With annual revenues of over $2.5 billion, at Watson Pharmaceuticals (NYSE: WPI) we dedicate ourselves daily to a singular mission, to improve the quality of life for patients around the world through the development and distribution of trusted generic and advanced, specialty branded pharmaceuticals.

Under limited supervision, performs the preparation, review and submission of pre- and post-approval submissions to the Food and Drug Administration, using governmental guidelines and regulations.  Carries out responsibilities in accordance with the organizations policies, procedures, and state, federal and local laws; prepares timely original ANDAs, amendments, supplements, annual reports, and other regulatory documents for review and approval by Manager; interfaces with other departments to provide Regulatory advice and obtain the necessary documents and drafts reports and narrative components in accordance with regulatory agencies? guidelines; prepares, assembles, compiles and publishes regulatory submissions in electronic (eCTD) as required; eviews and approves change controls, assigning the appropriate regulatory determination for eventual submission as required; communicate with Regulatory Agencies as directed; reviews, analyzes and generates technical documents from other departments or companies, e.g., summary of manufacturing processes, clarifications and explanations of Company procedures; evaluates and researches any submission deficiencies, additional information or testing as requested by regulatory authorities; participates in problem solving activities for assigned projects; reviews and updates departmental SOPs; performs special projects assigned by Regulatory Affairs management; complies with good housekeeping and safety practices; trains and coaches lower level Regulator Affairs Associates; ensures project deadlines and performance standards are established and met; and ensures compliance with all Company policies and procedures, including safety rules and regulations.

Qualifications Knowledge of  Current Food and Drug Administration (FDA) regulations and guidelines; current FDA/Regulatory Affairs submission requirements including eCTD format; logistics and work of the pharmaceutical industry; business, scientific and personal computer hardware and software applications; business English usage, spelling, grammar and punctuation; current Company policies, practices and procedures, including safety rules and regulations.

Skill in responding to routine inquiries from management, employees and regulatory agencies; communicating clearly and concisely, both orally and in writing; operating a personal computer; managing multiple projects, duties and assignments; applying Federal, state and local policies, procedures, laws and regulations; establishing and maintaining cooperative working relationships with others; ensuring compliance with all Company policies and procedures, including safety rules and regulations.

Incumbents in this class are subject to extended periods of sitting, standing and walking, vision to monitor and moderate noise levels.  Work is performed in an office environment.

Education Bachelors Degree in Chemistry or related field from an accredited college or university, and five (5) years work experience in the pharmaceutical industry or three (3) years of satisfactory performance as a Regulatory Affairs Associate II.

Please refer to job code 6796BR when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Morristown, NJ
County:	Morris County
ZIP Code:	07960
Pay Rate:	Open
Job Terms:	full time
Company:	Watson Pharmaceuticals
Phone:	email only please
Fax:	email only please