CAMRIS is seeking a Regulatory Affairs Scientist to join the team for a Regulatory Affairs proposal at the The Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear
Defense (JPEO-CBRND) in Aberdeen, Maryland.
To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.
- Experience in development and execution of Regulatory strategies and Operations from late S&T through FDA approval
- Experience in formulating regulatory strategies and communicating with FDA both in written submissions, regulatory meetings; experience as a panel member with FDA and FDA/pharmaceutical/academia representatives
- Experience in FDA drug submissions, approvals and launches, both as a regulatory SME writing submissions and as a strategic leader guiding the program
- Supervisory experience of high-level regulatory personnel who manage individual projects/programs that have successfully achieved FDA approval/clearance/authority.
- Experience as a regulatory advisor to senior management
- Experience in creating and managing teams comprised of decision analysts using best practice methods of decision analytics
- Knowledgeable in data warehousing capabilities used to create a longitudinal comparison of portfolio and corporate history; capability of developing a web-based portfolio analysis tool for drug discovery, as well as early and advanced drug development, with enabled viewing for senior management.
Candidates for positions under contracts with the Department of Defense (DoD) may be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency.
WORKING CONDITIONS/PHYSICAL DEMANDS:
Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Laboratory/office environment; may require working evenings and weekends. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to manipulate objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear. Work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually moderate.
Masters or better in Biodmedical Science or related field.
Experience in advising product development teams on regulatory issues.
Solid understanding of the FDA eCTD processes.
Experience in coordination of regulatory activities within internal and external teams.
Experience in GLP studies and GCP Regulations.
Experience applying FDA Title 21 CFR for clinical research, regulatory compliance and quality review of submissions to the FDA relating to product approval; regulatory affairs guidance and policy document development, regulations and guidelines to ensure FDA clinical research compliance, and regulations and guidelines to ensure compliance to design controls for the development of devices is required.
Prior experience as an FDA regulatory scientist or experience representing a sponsor before the FDA is required.
Experience in medical product development.
Must have understand the risk-based device classification system for medical devices and regulatory requirements of the three classes of medical devices (Class I, II, III devices).
Must be able to work independently following a brief period of specific technical training.