Director Of Regulatory Affairs Jobs in Florida

Job Title: Regulatory Affairs Manager Company: Biotest Pharmaceuticals Location: Boca Raton, FL Description: Regulatory Affairs ManagerTracking Code1293Job DescriptionSupervises and participates in the planning, preparing and interpreting regulatory documents for submission to governmental regulatory agencies such as the U.S. Food and Drug Administration.  Serves as a liaison with regulatory agencies and contractors, as well as an information source regarding product and assay development questions.  Ensures corporate policies and procedures comply with regulatory requirements. Provides accurate and timely regulatory guidance to the R&D, manufacturing, operations and quality staff while maintaining frequent contact with the Senior Director. Responsible for preparation, review, presentation, and evaluation of all FDA submissions to assure accuracy and completeness of submission documents including meeting/briefing packages/ and presentations to the FDA (e.g., pre-IND submission, end-of-phase II, pre-market application, and advisory committee meetings), New Drug Applications (NDAs), Orphan Drug Applications, Market Applications, INDs, (product and Establishment License Applications), and other related documents or CMC section submissions. Determines submission requirements and requests needed data, information, and documentation from pertinent departments, facilities, and affiliates, and from contractors/vendors as needed. Liaises with partner companies as appropriate. Provides signatory approval for reports and amendments to INDs/BLAs, assuring submission within specified regulatory timeframes. Reviews and approves for accuracy and completeness all materials to be included in submissions, including materials prepared by others and supplied to Regulatory Affairs. Required SkillsEffective written and verbal communication skills.  General knowledge of pharmaceutical development and federal regulations in pharmaceutical principles of document management.  Excellent program management skills.  Proficient in word processing packages.  Must be able to represent Biotest Biopharmaceuticals with accuracy and sensitivity to regulatory issues.  Detailed knowledge of: Federal Food, Drug and Cosmetic Act; Code of Federal Regulations; FDA guidelines; and Regulatory Affairs department SOPs. Ability to manage junior regulatory staff membersRequired ExperienceBachelor's degree in Pharmaceutical, Biological or Chemical Science or related field. Five plus years plus of practical pharmaceutical development regulatory experience at a management level in Regulatory Affairs with an emphasis on Biologics and BLA submission experience.Job LocationBoca Raton, FL, US.Position TypeFull-Time/Regular

Job Title: Regulatory Affairs Director Company: WellCare Health Plans Location: Tampa, FL Description: WellCare Health Plans, Inc. (NYSE: WCG) provides managed care services exclusively for government-sponsored health care programs, focusing on Medicare and Medicaid. A 2008 Fortune 500 Company headquartered in Ta, Florida, WellCare offers a variety of health plans for families, children and the aged, blind and disabled, as well as prescription drug plans. The Company employs approximately 3,800 associates and services nearly 2.4 million members nationwide as of June 30, 2009.At WellCare, we strive to be the leader in government-sponsored health care programs. Our actions must consistently demonstrate a high level of integrity that earns the trust of those we serve, and all of our associates must be responsible for the commitments we make and the results we deliver. To accomplish this, we must hire and develop the best possible talent, and create a fulfilling environment for our associates where diversity is valued, achievements are recognized and people of all backgrounds and talents are encouraged to grow. The Regulatory Affairs Director oversees the regulation process for products requiring governmental approval by ensuring that all necessary applications are filed and handling all government interactions develops procedures to ensure regulatory compliance and manages regulatory relationships with a broad spectrum of regulatory agencies, including Medicaid, Medicare, Commercial and SCHIP. Essential Functions: Oversees tracking and monitoring of regulatory developments and formal regulatory process Analyzes, researches, and seeks input regarding impacts of proposed regulations Develops consensus regarding policy positions and responses to proposed regulations Oversees and prepares organization for all regulatory audits, and ensures compliance with regulatory changes and manages policy development Manages and develops direct reports who include other management or supervisory personnel and/or exempt individual contributors Plans, conducts and directs work on complex projects/programs necessitating the origination and application of new and unique approaches Sets operational priorities and manages resources to operational goals and budgets Develops strategies and ensures maximum efficiencies in the utilization of human and financial resources With approval of Senior VP or VP, establishes budget and monitors for adherence Ensures corporate initiatives are implemented to achieve optimum results Education and Experience: Bachelor's level education in business administration or related field with a Master’s Degree in public policy, public health, political science, health administration or related field 10-15 years of combined experience in planning, development, health policy, regulatory policy, health care consulting or managed health care, and a proven track record of leadership experience in the health care industry 10 plus years progressively responsible managerial experience In-depth knowledge of government programs and the managed care industry and proven experience leading and managing regulatory affairs programs through teamwork, collaboration and open communication Computer Skills: Knowledge of Microsot Office including Outlook,Word and Excel Knowledge of and/or ability to utilize COGNOS for budgetary decisions or review