Collaborate with clinical trial management to ensure that all regulatory requirements are met and that the FDA is compliant. In addition, the site is to conduct the study.
Manage and track regulatory Affairs, marketing, and research activities, including but not limited to: The procurement of all relevant information, and prepare reports for the client.
Assist in the development of project plans, and other materials for the development of the project. Develop and implement the marketing plan for the company.
Provides technical support to the research and development team, including: Researching and developing new and existing contracts, and maintaining the business intelligence system.
Provide technical support to the customer, clients, and sales team, including the creation of a variety of correspondence and materials.
Develop, implement, and maintain a variety of research and marketing materials, including but not limited to: The following: filing, tracking, and retrieval of documents.
East Allegheny High School
Assist in the preparation of regulatory submissions for submission to the regulatory agencies, including the filing of the regulatory documents for submission to the FDA, and to ensure that the inspections are met.
Provide regulatory liaison to the regulatory Affairs and the FDA to ensure that all the documentation is completed and submitted to the appropriate authorities and/or the receiving IND.
Provide regulatory guidance to the global regulatory compliance team to ensure that the assessment of the products are in compliance with applicable regulations and standards.
Work with the regulatory Affairs department to ensure that the submissions are completed and submitted to the FDA. Review and approve all regulatory documents.
Manage and maintain regulatory documents for the submissions of the regulatory affairs. Provide input on the development of the annual reports.
Provide guidance and support to the clinical research associates and other clinical staff in the conduct of the study. Ensure that all regulatory documents are in compliance with the FDA and ICH guidelines.