Regulatory Affairs Manager/Director Job in Rockville 20850, Maryland Us
The EMMES Corporation, organized in 1977, is a privately owned Contract
Research Organization (CRO) located in Rockville, Maryland. EMMES is dedicated to providing statistical and epidemiological expertise, computer systems development, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in clinical and biomedical research. EMMES is seeking a Regulatory Affairs Manager/Director to support a variety of public health, clinical research projects.
RESPONSIBILITIES:
* Provide regulatory consulting for clients in order to assist them with the filings and approval processes for IND, NDA, BLA and ANDA submissions and electronic (eCTD eNDA/BLA) submissions of the previous mentioned.
* Conduct regulatory review of technical summaries, reports and administrative documents for regulatory filings.
* Assure submissions adhere to FDA/ICH regulations/guidelines.
* Provide internal training to Regulatory Operations group regarding Regulatory Issues including electronic submissions and CTD/eCTD.
* Serve as Regulatory Subject Matter Expert, as needed, in support of Process Consulting Group projects; includes consulting on FDA /Regulation Guidance interpretation, Electronic Submissions and Document Authoring/Publishing Processes.
* Manage the schedule and quality of work of his or her direct reports, as well as provide continued
* Serve as the regulatory liaison with the FDA, health authorities and other outside contacts