Angie Smith Email & Phone Number

Wesley Chapel, Florida, United States

Wesley Chapel, Florida, United States

• Compile and submit sequences for multiple application types to the applicable country / regulatory authority. • Review regulatory documents for accuracy and completeness with electronic publishing standards and resolve document issues.• Coordinate and complete assignments within the established scope of work while anticipating and mitigating risks to established timelines and identifying solutions.• Manage project plans and team activities, and track project information and timelines.• Assist clients in the development of publishing plans, timelines, and strategies.• Provide training and support to peers for compilation, publishing, and technical guidance.• Creation of internal technical documents such as: standard operating procedures, work instructions, and training tutorials.

Tampa, Florida, United States

• Responsible for the publication and submission of electronic filings to regulatory agencies to support clinical trials, new marketing authorizations, and approved marketing authorizations primarily for the U.S. • In charge of electronic document management systems (EDMS) software, document authoring templates, and submissions publishing tools and assists in the preparation of submission ready files for inclusion in eCTD submissions using these technical tools. • Responsible for working directly with directors and managers in planning, tracking, and executing required submissions and regulatory commitments. Acts as submissions representative on local and global project teams; provides resource and timeline estimates for publishing regulatory submissions, as well as provides electronic submissions expertise, as needed.• Involved in evaluating documents to meet electronic publishing standards, document quality control, and document processing activities associated with generating routine and complex regulatory documents for electronic submissions in accordance with regulatory guidelines.• Manages Romark’s archives related to submissions and correspondence from and to Health Authorities • Develops and maintains best practices for the Regulatory Operations team consistent with evolving FDA guidelines for electronic submissions. • Contributes to the writing, review, and implementation of standards, templates, and procedures related to the publishing, review, transmittal, and archiving of electronic regulatory documentation; recommends and helps implement associated process improvements • Analyzes new product projects and develops, and executes plans to bring new products into the Regulatory Operations electronic environment.

Tampa, Florida

• Assists in the preparation of regulatory submissions (INDs, NDAs, DMFs, amendments, annual reports, safety reports, information request responses, etc.• Works with Regulatory Affairs management to ensure that source documents are received in a timely manner in order to support the generation of submissions• Compiles and publishes electronic and/or paper regulatory submissions, working with appropriate team members feedback in case of any deficiencies and follow up to assure that any deficiency is remedied• Ensures relevant submission processes are applied to all assigned submissions, including coordinating the electronic component and dossier level publishing and production of regulatory submissions that conform to regional and country specific regulatory requirements as appropriate.• Liaises with external publishing contractors• Takes responsibility for and/or supervises the secure archiving (paper and electronic) of all original submissions made to regulatory authorities and other regulatory essential documents.• Keeps an up-to-date record of all correspondence with regulatory authorities• Liaises with internal teams and external partners, e.g., clinical sites, CROs, CMC suppliers, when necessary, to ensure that a complete record of submissions and correspondence with regulatory authorities is provided for regulatory filings• Researches/applies guidelines and regulations in the preparation of compliant and approvable filings • Assists in the development of Dossier Plans and the regulatory strategy seeking input from functional area representatives and key stakeholders, meeting regularly with submission stakeholders and representatives to identify and resolve issues and to assess quality and delivery of documents • Assists in monitoring application progress and preparation of progress reports • Anticipates regulatory obstacles and assists in the development of solutions• Coaches and mentors junior members of the regulatory team

-Maintain knowledge of and ensure compliance with employment-related laws and regulations. Conduct research regarding employment issues, benefits, workers compensation and personnel procedures. Advise on employment statutes, rules, regulations and policies affecting team members.-Manage actions and proceedings brought against DSS arising in connection with employment, benefits and workers compensation issues.-Assist in hiring, including developing job descriptions and job advertisements, and screening and interviewing candidates.-Prepare & maintain all personnel files, I-9 records, drug and alcohol screening and background investigation results, and other personnel records in compliance with all laws and regulations and demonstrates “best practices” in regard to personnel information management. -Provide leadership in effective conflict resolution for all personnel. Serve as a resource for team leaders in handling employee issues and assist them in counseling employees, conducting evaluations, staff training and problem-solving as well as serving as a resource for team members.-Organize and work independently on multiple assigned tasks/projects and complete assignments within specified deadlines. -Communicate effectively verbally and in writing to all levels of staffand management, outside officials and agencies, and expressing ideas and instructions clearly and concisely.-Develop and implement human resources programs and policies and periodically update Employee Handbooks. Oversee the Organizational Development & Training function and develop employee training programs. -Demonstrate skills critical for managerial success including leadership, decisiveness, flexibility, sound business judgment, and highly developed personal, analytical and communication skills. -Work well under pressure. -Accurately follow verbal and written directions from senior management.

• Accomplishes objectives such as recruiting, selecting, orienting, training, coaching, counseling, and disciplining employees; communicating job expectations; planning, monitoring, appraising, and reviewing job contributions; planning and reviewing compensation actions; enforcing policies and procedures• Handle major incidents that cannot be resolved by agents. Investigate customer's issues and resolve complaints.• Oversee all aspects of new member initiation including document completeness & input accuracy as well as upload to government agency.• Leading a team of customer service staff; assist in processing claims, and marketing relations.• Provide high-level administrative support by conducting research, preparing reports, handling information requests, and performing clerical functions such as preparing correspondence, receiving visitors, arranging conference calls, and scheduling meetings.