Type: Salaried, Exempt
Regulatory Affairs Specialist I/II/III reports to the Manager, Regulatory and Quality and is responsible for Regulatory Affairs (RA) activities at Lacerta Therapeutics, Inc. including those responsibilities listed below. This Job posting is open to entry level applicants (Regulatory Affairs Specialist I) and those with relevant industry experience (Regulatory Affairs Specialist II or III).
- Draft, edit and prepare regulatory submissions for filing with the US FDA
- Coordinate multi-disciplinary teams to compile regulatory submissions
- Coordinate with external partner companies on regulatory submissions
- Support pre-clinical and clinical project teams as the RA subject matter expert
- Review pre-clinical and process development reports for regulatory submissions
- Draft regulatory strategy documents for new products
- Support the Lacerta Therapeutics Quality System as needed
- Bachelor’s degree required, preferably in a scientific discipline
- Proficient with Microsoft Word, Excel and Project
- Experience in gene therapy, biologics or pharmaceutical Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing or Product Development
- 2-5 years’ experience in FDA regulated industry
- Working knowledge of FDA regulations including CGMPs, GLPs and GCPs
- Regulatory Affairs Certification
The physical demands 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. While performing the duties of this job, the employee is continuously required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; and stoop, kneel, or crouch. The employee must regularly lift and/or move up to 15 pounds and occasionally lift/or move up to 40 pounds. Specific vision abilities required by this job include close vision, peripheral vision, depth perception and the ability to adjust focus.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.