Regulatory Affairs Assoc I

Job Title Regulatory Affairs Assoc I AutoReqId 6792BR 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 close supervision, performs limited or routine duties in 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; drafts and prepares annual reports, including obtaining necessary components and makes initial determinations of content for review and approval by Manager; drafts end user letters and other general correspondence for review and approval by Associate III or Manager; creates various sections of ANDAs, amendments, and supplements for review and approval by Manager; assists in the preparation, assembly, compilation and publication of regulatory submissions in electronic (eCTD) as required; 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 recommends changes for departmental SOPs; complies with good housekeeping and safety practices; ensures project deadlines and performance standards are established and met; ensures compliance with all Company policies and procedures, including safety rules and regulations; and performs related duties as assigned.

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 scientific and personal computers.

? 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.

Physical Requirements and Working Conditions: 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 Associates Degree in Chemistry or related field from an accredited college or university, and three (3) year pharmaceutical industry experience.

Please refer to job code 6792BR 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