Regulatory Affairs Assoc II

Job Title Regulatory Affairs Assoc II AutoReqId 6793BR 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 general supervision, performs 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; prepares timely original ANDAs, amendments, and supplements, including interfacing with other departments to obtain the necessary components and drafts reports and narrative components in accordance with regulatory agencies? guidelines for approval by Manager; repares other regulatory documents such as annual reports for approval by Manager; prepares, assembles, complies and publishes regulatory submissions in electronic (eCTD) as required; reviews non-technical change controls and assigns appropriate regulatory determination for submission; 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 suggests updates departmental SOPs; performs special projects assigned by Regulatory Affairs management; 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.

Qualifications Knowledge of:

? Current Food and Drug Administration (FDA) regulations and guidelines.

? Current FDA/Regulatory Affairs submission requirements including eCTD.

? 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 scientific and 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.

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 Bachelors Degree in Chemistry or related field from an accredited college or university, and three (3) years related pharmaceutical regulatory affairs experience, or three (3) years equivalent pharmaceutical industry experience, or two (2) years of satisfactory performance as an Associate Regulatory Affairs I.

Please refer to job code 6793BR 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