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Job #03083

About our client Our client, based in Arizona, is a leading specialty pharmaceutical company focused on treating skin conditions. They are devoted to helping patients attain a healthy and youthful look and self-image. Our client has numerous leading branded prescription products in various therapeutic categories, like acne, fungal and skin infections. With a stable business in North America and an amazing track record of revenue, operating income growth and impressive gross profit margins, this is an exciting opportunity for someone to join a stable and profitable company. Position Location Regulatory Affairs Specialist Scottsdale, Arizona Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee the development of regulatory filings to FDA on behalf of the company 2) Prepare new applications for submission to FDA including NDAs, INDs, ANDAs, IDEs and PMAs 3) Work on developing IND submissions, NDAs, ANDAs, IDEs, PMAs, pre-market notifications and BLAs 4) Prepare related submissions to FDA including amendments, supplements, controlled correspondence and contact reports 5) Manage all relevant amendments and supplements to the filings including reports of changes and annual reports 6) Prepare pre-approval supplements for FDA 7) Make post-approval reports and filings for FDA 8) Prepare annual reports for submission, which may include simple updates or more complex filings 9) Prepare periodic adverse event reports (annually and quarterly) for FDA 10) Meet with RA Director (on a weekly basis) and colleagues regarding project status, issues and concerns 11) Prepare status reports (monthly) for RA Director 12) Review advertising and promotional materials (weekly) 13) Represent RA at in-house discussion (FAC) 14) Attend meetings with Project Team, consultants and vendors related to projects (as needed) 15) Attend professional meetings and seminars for continuing education (as needed) 16) Prepare and distribute FDA contact reports (as needed) 17) Use professional initiative to develop submissions 18) Schedule meetings, solicit documents and assess change controls (as required) 19) Review technical data and conduct other information-gathering activities in the course of completing an assignment 20) Establish and maintain a schedule for completing routinely scheduled submissions 21) Review and authorize promotional materials Requirements 1) Baccalaureate degree from an accredited college or university in Life Sciences, Pharmacy, Chemistry or Nursing 2) Minimum 3 years of internship or professional experience in pharmaceutical, biologic, device, cosmetic, veterinary or food regulatory affairs (or 2 years of experience with a Master’s degree) 3) Ability to be proficient in the basic tasks within a year of starting 4) Ability to complete more complex tasks compared to Specialist I position