Noblesville, IN, United States
About Curium
Curium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.
With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name 'Curium' honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline 'Life Forward' represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.
The Senior Manager of Regulatory Affairs is responsible for Nuclear Medicine Regulatory Affairs dossiers and associated regulatory affairs activities in the US. The responsibilities include, yet are not limited to, defining and or authoring compliant content for new and existing dossiers, implementing and managing tracking systems, and preparation of electronic submissions. This position requires a highly skilled and experienced individual capable of navigating the complex regulatory landscape related to CMC. The main focus of this position will be on new submissions associated with new chemical entity (NCE) with a secondary focus on existing marketed products or those obtained through acquisition.
This position will facilitate the success of key regulatory projects that may require concept building, Target Product Profile (TPP), claims definition, regulatory strategy (including non-clinical and clinical), Non-clinical and clinical protocol review, defining dossier Table of contents, submission building, health authority management, obtaining approvals, managing post-approval commitments, and product launch. The regional focus for project deliverables is North America, that is, Food and Drug Administration and Health Canada, although the position will rely on the Canadian RA staff for country-specific regulations.
The Senior Manager Regulatory Affairs will directly participate in project teams managing key projects, regulatory deliverables, prioritization, strategy, providing guidance, and tracking regulatory process. The Senior Manager is expected to be able to identify risk and make risk-based decisions to facilitate solutions for process and submission. The candidate will direct and mentor less experienced staff on Risk-Based Decision making.
Working Conditions:
Disclaimer
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Equal Opportunity Employer
Curium is anequal opportunity employerand believes everyone deserves respect, dignity and equality.All applicants will be considered for employmentwithout attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Job Segment:
Regulatory Affairs, Compliance, Medical Technologist, Medical Research, Clinical Research, Legal, Healthcare