What are the responsibilities and job description for the Regulatory Affairs Specialist - Publishing position at Curium Pharma?
St. Louis, MO, United States, 63146
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 Regulatory Affairs Specialist - Publishing is responsible for leading the electronic publishing process and providing end-to-end submission support to the North America regulatory team. This includes formatting, compiling, and publishing submission-ready documents into compliant eCTD sequences for INDs, DMFs, BLAs, NDAs, ANDAs, and other regulatory applications. The Specialist will serve as the primary publisher for the US and Canadian Regulatory Affairs teams, collaborating closely with authors and project teams to ensure timely, high-quality submissions to health authorities.
Work Schedule: Monday - Friday 8am - 4:30pm
- Format MS Word and Adobe PDF files to be submission-ready according to department standards and health authority requirements
- Create hyperlinks and bookmarks within and across documents/sections
- Compile, validate, and publish eCTD sequences, ensuring accurate metadata and structure
- Coordinate publishing timelines with RA team and other stakeholders to meet project deadlines
- Maintain records and correspondence in the regulatory tracking system
- Provide guidance and training to authors on document formatting, submission standards, and lifecycle updates
- Identify and implement process improvements to enhance publishing efficiency and quality
- Troubleshoot and resolve technical publishing issues, escalating when necessary
- Stay informed on updates to FDA, ICH, and eCTD guidance
- 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.).
- Bachelor's degree in relevant field of study.
- A minimum of 1-3 years of hands-on experience with publishing, and compiling eCTD submissions using publishing tools (e.g., Lorenz DocuBridge, Extedo, or similar). Experience with electronic submission publishing software and applications
- Knowledge of FDA, ICH, and Health Canada submission requirements preferred. Excellent communication, interpersonal, time management, and organizational skills.
- Close attention to detail required.
- Ability to work autonomously under limited direction on multiple projects simultaneously
- Demonstrates a working knowledge of publishing technologies/software.
- All employees must read, write and speak fluent English
Working Conditions:
- This position will work in typical office conditions with extensive time using computer equipment.
- Close attention to detail required.
- Willingness to work in a team-based environment.
- May be required to sit or stand for long periods of 8 hours a day while performing duties.
- Must possess good hand-eye coordination; close attention to detail is required.
- Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
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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