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Wisconsin based NRC Approved Construction Project – Regulatory Specialist

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SHINE is 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 agencies
Serve as liaison between SHINE and regulatory bodies such as the FDA and EMA
Review and provide updates to the Drug Master File and communicate updates with the FDA
Develop/update the Site Master File
Ensure regulatory compliance though internal audits and checks to ensure compliance with the agency regulations
Act as primary contact for customer audits
Perform supplier audits
Communicate with all SHINE Therapeutic employees and discuss regulations, standards, and company policies with the aim of providing training and or education
Review of any incident data and carry out necessary root cause analysis
Reviewing marketing, legal and technical documentation to assess compliance
Must be able to work independently, set schedules, manage to timelines
Assist other projects and departments, as required
Up to 15% travel may be required
Overtime may sometimes be necessary to complete required work assignment with little or no advance notice
Qualifications:

BS/MS/PhD in Engineering or Science discipline
Minimum 7-10 years of equivalent experience
Experience in pharmaceutical regulatory requirements, audits and authoring DMF’s
Experience in radiopharmaceutical industry is strongly desired


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