Regulatory Affairs Assoc II Operations

Our Strength Is Our People. Passion. Principles. Perspective. At Watson, they're the traits that drive our growth and we apply them to every project and product. If you bring these qualities to your work, then we'd like you to consider joining our team.Under general supervision, prepares, compiles, reviews, corrects, collates, copies and submits all required Food and Drug Administration (FDA) submissions, such as ANDA's, adverse events, annual reports, supplements and amendments, using governmental guidelines and regulations. Uses document management system to collect, organize and prepare documents for submission to FDA.
Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
Prepares, reviews, and consolidates relevant documents from other departments for inclusion in submissions to regulatory agencies, e.g., annual reports, adverse drug events, amendments and supplements, periodic reports and notifications according to regulatory agencies' guidelines.
Collates, copies and submits FDA submissions as directed.
Responsible for preparing and filing amendments and supplements to applications as required.
Work with other company sites to discuss scheduled FDA submissions.
Assist with the maintenance of tracking the regulatory documentation utilizing appropriate database applications.
Assist with the maintenance of the ANDA correspondence books in the Regulatory library.
Ensures compliance with all Company policies and procedures, including safety rules and regulations.
Performs related duties as assigned.

Qualifications
Two (2) to four (4) years pharmaceutical industry experience, one (1) of which must be in Regulatory Affairs, and experience with a document management system (Livelink preferred); or an equivalent combination of education and experience.
Food and Drug Administration (FDA) regulations and guidelines.
Current FDA/Regulatory Affairs submission requirements.
Document management experience within the pharmaceutical industry.
Computer database and/or electronic document management experience.
Business English usage, spelling, grammar and punctuation.
Current Company policies, practices and procedures, including safety rules and regulations.

Watson offers competitive medical and dental benefits, including vision, 401(k) and educational reimbursement.Watson Pharmaceuticals, Inc. is an Equal Opportunity Employer M/F/D/V. We value the benefits of diversity.Apply Online Now! To apply for this position, please click here.