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Manager of Regulatory Affairs

Date:  Sep 23, 2021
Location: 

Maryland Heights, MO, 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.

 

Summary of Position

The Manager of Regulatory Affairs is responsible for Nuclear Medicine Regulatory Affairs dossiers and associated regulatory affairs activities in the US.  This position serves as a regulatory leader heading the Chemistry Manufacturing Controls dossier modules.  The responsibilities include, but are not limited to, defining and authoring compliant content for new and existing regulatory filings, implementing and managing tracking systems, and preparation of eCTD module content for electronic submissions.  This position may include work on new product applications associated with new chemical entities (NCE), as well as products already in non-clinical and/or clinical studies.  This position will also work on existing marketed products or those obtained through acquisition.

This position will facilitate success of key 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 content, content authoring, submission compilation, health authority management, responses to health authority, 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 Manager of Regulatory Affairs will actively participate on project teams by managing/contributing to regulatory key project deliverables, prioritization, strategy, and tracking regulatory process.  The Manager of Regulatory Affairs 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.

Essential Functions

  • Manage submissions and projects as assigned by the Director of Regulatory Affairs assuring compliance, planning, and execution.
  • Process, interpret and provide recommendations for complex strategies.  
  • Provide regulatory guidance to cross-functional teams and other personnel on health authority requirements and preparation of information/technical data needed for support of new product applications
  • Critically review documentation for regulatory submissions and provide input for necessary revisions.
  • Define Target Product Profile and build compliant drug “approvable” dossiers and registration.
  • Serve as Liaison for third party service providers.
  • Create and maintain database for tracking individual and department project deliverables.
  • Implement policies, procedures, practices, and strategies for Regulatory Affairs.
  • 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. 
  • Monitor and 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.

Requirements

  • Bachelor of Science in Chemistry, pharmacy, biology or other life science, plus direct experience managing regulatory activities
  • 7 years of overall experience required; five years or more of direct Regulatory Affairs experience, experience in the pharmaceutical or nuclear medicine industries is highly preferred
  • 2 years of experience supervising direct reports
  • Direct experience with authoring/compilation of eCTD dossier modules is required
  • Experience writing Target Product Profile
  • Experience with Non-clinical studies
  • Experience reviewing Clinical protocols and summary reports
  • Experience in preparation/execution of Health Authority meetings
  • Experience in leading new product application efforts including strategy, compilation, submission, and approval by a health authority
  • Strong knowledge of FDA/GMP requirements
  • Strong organizational skills, strong attention to detail, ability to problem solve, and effective in working with cross-functional teams.
  • Excellent written and oral communication skills.
  • Experience with electronic systems for preparation of eCTD submissions to FDA.

 

Organizational Relationships / Scope

This position reports to the Director of Regulatory Affairs for Nuclear Medicine North America. This position may have several direct reports with a larger team possible in the future.  Effects of decisions are long lasting.  This position represents Curium as a prime regulatory 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.

 

Working Conditions

  • Standard office environment.
  • Willingness to work in a team based environment. 
  • May be required to sit or stand for long periods of time while performing duties. 
  • Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
  • Responsibilites also include the ability to lift, walk, bend, stoop, push, pull, reach and climb stairs with or without accomodation. 

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 an equal opportunity employer and believes everyone deserves respect, dignity and equality.  All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

 


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