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.

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.
• 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.
• 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.
• 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.

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.
• 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.

-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.

• Accomplishes objectives such as recruiting, selecting, orienting, training, coaching, counseling, and disciplining employees; communicating job expectations; planning, monitoring, appraising, and reviewing job.
• 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.