The Manager of Regulatory Affairs – New Products is responsible for Nuclear Medicine Regulatory Affairs dossiers and associated regulatory affairs activities in the US. The responsibilities includes, but not limited to, defining and or authoring compliant content for new and existing dossiers, implementing and managing tracking systems, and preparation of electronic submissions. The main focus of this position will be on new submissions associated with new chemical entity (NCE) as well as products already being testing in non-clinical and or clinical studies. This position will have secondary focus on existing marketed products or those obtained through acquisition.
This position will facilitate 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. This position will work closely with the regulatory leader heading the Chemistry Manufacturing Controls dossier modules. 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 Regulatory Manager would participate on project teams managing key projects, regulatory deliverables, prioritization, strategy and tracking regulatory process. The RA Manager is expected to be able identify risk and make risk based decisions to facilitate solutions for process and submission. The candidate will mentor less experienced staff on Risk Based Decision making.
Manage submissions and projects as assigned by Regulatory Head assuring compliance, planning, and execution Process, interpret and provide recommendations for complex strategies. Critically review documentation for regulatory submissions and provide input for necessary revisions.
Define Target Product Profile and build compliant drug and device “approvable” dossiers and registration.
Serve as Liaison for third party service providers supporting Nuclear Medicine.
Maintain associated compliance database for tracking individual and department project deliverables for New Submissions and RA Compliance.
Implement policies, procedures, practices, and strategies for Regulatory Affairs.
Develop and implement in alignment with regional RA taking local considerations into account.
Manage multiple, sometimes conflicting priorities, define issues and obstacles, define risk analysis and execute solutions.
Execute objectives in alignment with Regulatory Head, Marketing and Global Business Units.
Coordinate communication between the Global Business Units and the Regional Regulatory Affairs staff resulting in a collaborative relationship.
Communicate regulatory governmental policy changes to management in a timely manner and provide plans for meeting and complying with new requirements. Understand and recommend strategies based on current local registration requirements and applicable industry standards
Mentor RA staff.
Present to upper management at required intervals and effectively communicate successes and challenges.
Bachelor of Science in Chemistry, pharmacy, biology or other life science, plus direct experience managing regulatory activities
10 years Pharmaceutical Industry Experience
Experience writing Target Product Profile
Experience with Non-clinical studies
Experience reviewing Clinical protocols and summary reports
Preparing for and executing Health Authority meetings
Experience in leading new project submission efforts including strategy, compilation, submission and approval by a health authority
6-8 years Regulatory Experience or Related Field
3-4 North American trips per year are possible.
Organizational Relationships / Scope:
This position reports to Head of Regulatory Affairs for Nuclear Medicine North America. This position currently has no direct reports but future reports are possible. Effects of decisions are long lasting.
This position represents organization as a prime contact on projects. Routine contact with other departments and external vendors is required of this position. This positional also interacts with senior internal and external personnel.
Relocation assistance provided on an as needed, case by case basis. EEO
Additional Salary Information: 10% Bonus and Excellent Benefits!
Curium was formed in 2017 through the union of IBA Molecular and Mallinckrodt Nuclear Medicine LLC. Curium is a world-class nuclear medicine solutions provider with over 100 years of combined industry experience. We are proud to service over 14 million patients worldwide each year and strive to provide best-in-class quality products and exceptional, reliable service.
Our diverse group of ind...ustry experts is unified under one strong and singular focus – to develop, manufacture and supply SPECT, PET and therapeutic radiopharmaceuticals to customers around the globe. In fact, we have over 6,000 customers in over 70 countries world-wide.
At Curium, every single dose counts in helping doctors and patients diagnose and treat disease. That means every single employee counts toward meeting this unified objective to help each patient live “Life Forward”. We have an amazing team that lives by our core values every single day – integrity, commitment and collaboration. Our North American headquarters is in Maryland Heights, MO. Come grow with us!