Mgr, Regulatory Affairs

Job Title Mgr, Regulatory Affairs AutoReqId 6795BR 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.

This manager will be responsible for successfully filing original Abbreviated New Drug Application submissions and for managing post approval changes requiring regulatory submissions. Can be primary contact with regulatory authorities for assigned projects and products. Determines nature and scope of information to be generated to successfully file required regulatory documents. Keeps Company informed of significant regulatory issues that affect assigned products/projects.

The essential job functions are as follows: Carries out managerial responsibilities in accordance with the organizations policies, procedures, and state, federal and local laws; directs, coordinates and prioritizes the daily activities of the assigned staff; reviews and approves regulatory submissions (i.e. ANDAs, amendments, supplements, etc.) to the Food and Drug Administration (FDA) to ensure compliance with applicable regulations and guidances; interacts with various departments as needed on regulatory issues and/or strategy. Effectively guides, communicates and implements determined strategy with the appropriate departments and/or employees; review and approve change notices, specifications, batch records, standard test methods, etc.; implements policies to assure on-going compliance of Regulatory Affairs activities; assesses impact of new regulations and suggests appropriate changes to business processes/policies as necessary; interacts with the FDA to facilitate approval of the regulatory submissions; maintains awareness of all regulatory activities on assigned projects. Works to minimize regulatory issues and helps prevent unnecessary regulatory delays; interacts with outside consultants and or contractors as needed; troubleshoots data and resolves problems with technical issues such as test methods and instrumentation; provides support, direction and coaching to subordinate employees in the areas of hiring, training, disciplinary action, problem resolution, planning, and work assignment delegation; conducts performance evaluations for direct reports; meets project deadlines and established performance standards; complies with all Company policies and procedures, including safety rules and regulations, and guides subordinates in this area.

Qualifications

Knowledge of FDA, SOP and cGMP standards, guidelines and regulatory compliance regulations; pertinent Federal and State laws related to pharmaceutical regulatory affairs; supervision and training practices and methods; business, scientific and personal computer software applications; business English usage such as, spelling, grammar and punctuation; recruiting, interviewing and selecting of applicants in accordance with established employment practices and methods; Company policies, practices and procedures, including safety rules and regulations; and principles and practices of budget preparation and administration.

Skill in creating, planning and implementing group goals, objectives and practices for effective, efficient and cost effective management of allocated resources; responding to general and/or sensitive inquiries from management, employees and regulatory agencies; preparing, presenting and administering budgets and financial reports; communicating clearly and concisely, both orally and in writing; managing multiple projects, duties and assignments; interpreting and applying Federal, state and local policies, procedures, laws and regulations; directing, coordinating, delegating assignments and reviewing the work of assigned department personnel; establishing and maintaining cooperative working relationships with others; and 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, moderate noise levels and frequent business travel. Work is performed in an office environment.

Education

Minimum Qualifications:

Bachelors of Science Degree from an accredited college or university, and six (6) years relevant work experience with at least one (1) year supervisory experience; or an equivalent combination of education and experience.

Please refer to job code 6795BR 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