The Regulatory Affairs Project Manager will support regulatory affairs in formulation and execution of regulatory strategy and authoring of regulatory documents for submission to various Health Authorities. This includes providing support for all activities related to Health Authority meetings, requests for information and other queries from Health Authorities and other Regulatory Intelligence activities. The Regulatory Affairs Project Manager will be responsible for interpreting regulatory guidances and relaying key points to regulatory affairs and senior leadership. This position is also responsible providing training and mentoring to junior staff.
The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.