Sr. Regulatory Affairs Associate

SENIOR REGULATORY AFFAIRS ASSOC SUMMARY OF POSITION: Sr. Regulatory Affairs Associate is a position in the Regulatory Affairs department for individuals with direct regulatory affairs experience and a BS in a scientific discipline. This position acts as a point of contact with regulatory authorities for questions and issues regarding specific applications. They will work with significant levels of autonomy in the coordination and execution in the assembly and approval of drug applications to regulatory authorities, including the collection and collation of data/information, and writing needed to complete an application. ESSENTIAL FUNCTIONS: 1. Assemble NDAs/ANDAs and other regulatory applications for drugs - develop new or amend existing applications: collect relevant/information from other departments, write the application, assist Associates on assembling components of the application, and review application for accuracy and completeness following regulatory guidelines. Sign off on applications as responsible agent. 2. Anticipate regulatory consequences - develop and maintain knowledge of the history, manufacture, and materials of assigned products and product lines in order to assess (1) the consequences of regulatory changes for the product and (2) the regulatory consequences of changes in the manufacture, materials, or marketing of the product. 3. Maintain high level of knowledge of regulations, the regulatory process, and the application of regulations to assigned products - expand regulatory background through work on projects, researching available documents and attending relevant training. Anticipate how future developments in the regulations and standards governing regulatory submissions may affect company policy and applications. 4. Represent Regulatory on Core Teams in the Product Development Process. Develop regulatory strategy for projects in various stages of development. Defend regulatory position both internally and externally. Negotiate agreement to novel approaches to problem solving. Liaison with other regulatory functions and clinical team to provide cohesive strategy and timelines for product development process. 5. Liaison with FDA and contacts outside of company. Determine specific needs and organize the assembly of an appropriate response. Effectively communicate issues from FDA to other department personnel and company issues to FDA. 6. Prepare submissions in an electronic document management system. Requires advanced computer skills, organizational planning and ability to multi-task. 7. Process, interpret and provide recommendations for complex, unusual issues. 8. Critically review documentation for regulatory submissions and provide input for necessary revisions. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Minimum educational experience requires a BS in Chemistry, pharmacy, biology or other life science.Requirements: Experience1. Successful candidates will have a minimum of 6 years experience in pharmaceutical regulatory affairs or equivalent regulatory affairs and pharmaceutical industry experience. 2. Previous FDA submissions required. 3. Must have knowledge of required CMC documentation. Preferred Skills/Qualifications 1. Knowledge of Windows based software programs such as Word, Excel and Access. 2. Background in manufacturing, marketing, quality assurance sufficient to understand how products are produced and marketed. 3. Understands regulatory application process and the basis of regulations. 4. Background in the chemical and life sciences sufficient to interpret data/information, review the work of others for technical accuracy and adequacy, draft application, and interact with reviewers. 5. Familiarity with pharmaceutical manufacturing equipment and technology is of value for this position. Skills/Competencies 1. Fundamental knowledge of federal acts and regulations affecting proposed and marketed products. 2. Excellent oral and written communication skills. 3. Strong interpersonal skills, including ability to remain calm, professional, diplomatic and positive. 4. Capable of making consistent, sound regulatory decisions. 5. Must be able to work with minimal supervision. 6. Must work well under tight and conflicting deadlines. 7. Must be detail oriented and be proficient at reviewing and editing documentation. 8. Allocates own time effectively.To apply online, please use the following link: Apply To Covidien Click here to see all “Covidien� opportunities Visit our web site to learn more about Covidien EMAIL THIS JOB TO A FRIENDCOVIDIEN, COVIDIEN with Logo and "positive results for life" are trademarks of Covidien AG. ©2007 Covidien AG or its affiliate. All rights reserved.