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(Contractor) Senior Manager Regulatory Affairs

3 months ago

Noblesville, United States Curium Full time
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 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.

Essential Functions

  • Manage submissions and projects as assigned by Regulatory leadership assuring compliance, planning, and execution
  • Represent regulatory on cross-functional teams
  • Process, interpret and provide recommendations for complex strategies
  • Provide regulatory and technical expertise to cross-functional teams
  • Critically review documentation for regulatory submissions and provide input for necessary revisions
  • Develop and implement regulatory strategies for CMC aspects of drug development and registration
  • Lead the preparation and submission of CMC sections of regulatory documents (e.g., INDs, NDAs, BLAs, MAAs) in compliance with global regulations and guidelines
  • Contribute to defining Target Product Profile and build compliant drug "approvable" dossiers and registration
  • Serve as Liaison for third party service providers
  • Maintain associated database for tracking individual and department project deliverables for regulatory submissions and milestones
  • Develop and implement policies, procedures, practices, and strategies for Regulatory Affairs, based on current Health Authority guidelines and regulations
  • Manage multiple, sometimes conflicting priorities, define issues and obstacles, define risk analysis and execute solutions
  • Execute objectives in alignment with Regulatory leadership, Marketing, and Global Business Units
  • 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
  • Supports the professional development of regulatory staff through mentorship and guidance
  • Present to upper management at required intervals and effectively communicate successes and challenges
  • Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)
Requirements
  • Bachelor of Science in Chemistry, pharmacy, biology or other life science, plus direct experience managing regulatory activities.
  • Twelve or more years of relevant Regulatory Affairs pharmaceutical industry experience.
  • Two years of supervisory experience of direct reports required, matrix management experience preferred.
  • In-depth knowledge of global CMC regulatory requirements, guidelines, and industry practices.
  • Experience in leading new project submission efforts including strategy, compilation, submission, and approval by a health authority.
  • Experience writing Target Product Profiles, non-clinical studies, reviewing Clinical protocols and summary reports.
  • Preparing for and executing Health Authority meetings.
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.
  • Close attention to detail required.
  • Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.


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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