(Contractor) Regulatory Affairs Specialist

1 week ago

St Louis, United States Curium Pharma Full time


(Contractor) Regulatory Affairs Specialist

Date:

Nov 12, 2024

Location:


St. Louis, 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 (Contractor) Regulatory Affairs Specialist responsibilities encompass the support of international drug product applications. Support of regulatory activities including but not limited to:

  • Plan/author/compile drug product dossiers in CTD format for expansion to international markets
  • Plan/author/compile/submit/manage variations for marketed products outside the United States
  • Respond to health authority information requests and comments to achieve approval
  • Review and assess CMC regulatory impact and provide regulatory strategy for post-approval changes proposed at the manufacturing site
  • Participate in cross-functional teams and provide health authority requirements needed for support of initial international filings and post-approval changes
  • Facilitate the creation of foreign language labeling content to meet local health authority requirements
  • Maintain regulatory knowledge of current guidelines and regulations
  • Maintain current regulatory databases and produce various reports as needed
  • Provides mentorship for entry-level regulatory associates

Essential Functions
  • Authoring, organization, and preparation of CTD regulatory filings; also includes peer review of filings
  • Understand, identify potential regulatory risks and recommend strategies based on current ICH and health authority requirements
  • Manage multiple priorities
  • Attend necessary trainings and seminars to keep abreast of new and/or changes in the Regulatory profession.
  • Process, interpret, and provide recommendations for complex, unusual issues.
  • Critically review documentation for regulatory submissions and provide input for necessary revisions.
Requirements
  • Bachelor Degree in scientific discipline required or equivalent work experience.
  • 3 or more years ofRegulatory experience or related field required.
  • Self-starter who takes initiative to learn, grow and excel as a Regulatory Affairs professional.
  • Background in manufacturing, research and development, or quality assurance sufficient to understand how products are produced and marketed.
  • Strong organizational skills, strong attention to detail, ability to problem solve and to work well with others and cross-functionally.
  • Cross-functional interaction experience, coordinating activities, driving assigned submissions to completion, and working to align communications with other departments is required.
  • Excellent written and oral communication skills.
  • Use of software system to manage change controls.
  • Strong background using Microsoft Office tools and Adobe Acrobat.
  • Travel Time Required - up to 10% (May vary depending on region/site)

Working Conditions:

  • Standard office environment
  • Willingness to work in a team-based environment.
  • Close attention to detail required.
  • May be required to sit or stand for long periods of time while performing duties.
  • Must be able to work outside of regular work hours.
  • Responsibilities also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation.
  • Must possess good hand-eye coordination.

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.



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