Regulatory Specialist - Military veterans preferred

System One


  full-time   part-time   employee   contract

United States

Immediately seeking Regulatory Specialist to fill an exciting new role in a growing team dedicated to developing non-carrier added lutetium-177 for cancer therapies. The Regulatory Specialist will lead and support the Therapeutics teams interactions with the FDA and other drug regulatory bodies as well as support internal and external auditing programs. As a strong communicator, this individual will lead our efforts in regulatory submissions including DMF’s and revisions, drive meeting requests and any other required interactions. This person will also be handling customer audits and will perform internal and supplier audits. It is expected that they will works in collaboration with all of our departments and be able to provide positive reinforcement and guidance in pharma guidelines. A background in radiopharmaceuticals is preferred.Duties and Responsibilities:Serve as author and main reviewer for all pharmaceutical related submissions to the FDA or other agenciesServe as liaison with regulatory bodies such as the FDA and EMAReview and provide updates to the Drug Master File and communicate updates with the FDADevelop/update the Site Master FileEnsure regulatory compliance though internal audits and checks to ensure compliance with the agency regulationsAct as primary contact for customer auditsPerform supplier auditsCommunicate with all Therapeutic employees and discuss regulations, standards, and company policies with the aim of providing training and or educationReview of any incident data and carry out necessary root cause analysisReviewing marketing, legal and technical documentation to assess complianceMust be able to work independently, set schedules, manage to timelinesAssist other projects and departments, as requiredUp to 15% travel may be requiredOvertime may sometimes be necessary to complete required work assignment with little or no advance noticeQualifications:BS/MS/PhD in Engineering or Science disciplineMinimum 7-10 years of equivalent experienceExperience in pharmaceutical regulatory requirements, audits and authoring DMF’sExperience in radiopharmaceutical industry is strongly desired