Crystal Equation
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Pay range is $35 - $40 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
THE PROMISES WE MAKE:
At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.
Regulatory Affairs Planning Resource I
Responsibilities:
Regulatory Affairs Planning Resource I
1 Astellas Way Northbrook, IL 60062 US
Posted: 01/30/2024
2024-01-30
2024-03-22
Job Number: 38606
Job Description
Pay range is $35 - $40 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
THE PROMISES WE MAKE:
At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.
Regulatory Affairs Planning Resource I
Responsibilities:
- Responsible for developing regulatory CMC strategy for assigned projects.
- Identifies and collects CMC data required for regulatory submission packages.
- Plans and prepares CMC regulatory packages, assesses changes for potential regulatory impact, responds to action letters, and maintains filings and approvals.
- Utilizes working knowledge of CMC to effectively interpret CMC development and changes and determine the impact on the project or product and the application.
- Acts as CMC regulatory lead or deputy for complex projects/products, requiring advice from manager on complex issues
- Manages technical documents for preparation, review and submission to regulatory agencies.
- Prepares INDs/CTAs & NDAs/MAAs, amendments & supplements, as well as responses to questions from regulatory agencies.
- Assesses scientific data against regulatory requirements and reviews submissions against regulatory strategy.
- Ensures proper CMC Dossier Management, including document version control.
- Ensures compilation and transmittal of submissions are within defined schedules and meet Health Authority and our own established standards/SOPs.
- Develops approach for new assignments having less-defined regulatory frameworks with management oversight.
- For assigned projects, monitors and facilitates resolution of CMC issues that have potential for regulatory impact.
- Regularly interacts with functional peer groups internally and externally, occasionally with senior management.
- Advises local teams on regulatory requirements.
- Interprets and ensures compliance with applicable Health Authority/ICH regulations.
- Stays informed of changes in Health Authority regulations and expectations, and shares lessons with others.
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Ready to launch your career in the vibrant Northbrook, Illinois area? The opportunities here are as diverse as they are exciting! Nestled in the heart of Cook County, Northbrook offers a unique blend of urban amenities and suburban charm. Enjoy easy access to renowned attractions like the Chicago Botanic Garden, Allstate Arena, and Ravinia Festival, where music and culture thrive. Immerse yourself in the local scene with a wide array of culinary delights, from deep-dish pizza to gourmet dining experiences. With top-notch galleries, theaters like the North Shore Center for the Performing Arts, and professional sports teams like the Chicago Bears and Blackhawks just a short drive away, there's never a dull moment in Northbrook. Embrace a career in this dynamic region and unlock endless possibilities for professional growth and personal fulfillment. Explore our job listings today and take your career to new heights!