Ionetix Corporation is seeking a Director of Regulatory Affairs to maintain successful regulatory compliance for Ionetix.
This role will consist of regulatory oversight and execution, ensuring control, efficiency, documentation, and compliance of business processes and products.
Ionetix is a growing company, with revolutionary cyclotron technology with headquarters in Lansing, MI.
We have full isotope production and processing, drug manufacturing, and distribution logistics.
In this role, you’ll have the opportunity to work with a fantastic group of individuals who are all dedicated to having careers with a purpose.
In this role you’ll will:
Develop and advance expertise in drug regulatory knowledge and strategy to ensure adherence to Diagnostic and Therapeutic drug regulations (21 Code of Federal Regulations (CFR) Part 210, 211, 212, and 11), as well as licensing requirements, thereby ensuring compliance with state and federal laws and regulations.
Improve and sustain awareness of current requirements and remain updated on proposed changes to Good Manufacturing practice (GMP) requirements.
Effectively communicate the proper application of these requirements internally.
Manage the compilation of Food and Drug Administration (FDA) submissions, including lifecycle management.
Stay informed about regulatory updates and changes, and propose appropriate adjustments and recommendations to policies, practices, and procedures.
Active participation and support in the Stage Gate process.
Contribute to internal audits, providing reports and recommending corrective actions.
Lead and participate in regulatory inspections, ensuring timely filing of documents, records, reports, or responses.
Qualifications:
Bachelor’s degree in a science or related field of study
10 years of progressive work experience in regulatory assurance, quality assurance, quality management systems, documentation control, and International Organization for Standardization (ISO) certification
3 years of direct experience in regulatory oversight Working knowledge in Positron Emission Tomography (PET) GMP, United States Pharmacopeial Convention (USP) and 21 CFR Part 210, 211, 212.
Experience in PET drug Abbreviated New Drug Application (ANDA) application process and lifecycle; Experience with Drug Master File (DMF) process
Inspection experience (i.
e.
FDA, Nuclear Regulatory Commission (NRC), BOP)
Ionetix is an Equal Opportunity Employer.
Whatsapp
