Scientist I - CMC

Cardinal Health

2d•$32 - $40•Remote

About The Position

The Scientist I - CMC supports regulatory activities for pre-approval, post-approval changes, and lifecycle management across client Rx and non-Rx products. Working as a consultant, this role assists in the preparation, review, and coordination of regulatory documentation, while ensuring alignment with applicable regulatory requirements and client expectations. The individual will collaborate closely with cross-functional teams and contribute to the timely delivery of high-quality regulatory submission content.

Requirements

Bachelor's degree in related field, or equivalent work experience (Pharma QA, QC, Analytical Development), preferred
Familiarity with core CMC concepts (e.g., manufacturing, control strategy, change management) and general awareness of post-approval variation requirements across major health authorities (e.g., FDA, EMA, NMPA, PMDA, ANVISA, TGA, Health Canada) is preferred.
Understanding and application of scientific principles and techniques used in pharmaceutical product development
Knowledge and experience with cGMP regulations and ICH guidance.
Experience with writing global regulatory applications in CTD format highly preferred
Basic proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Working knowledge of Adobe Acrobat for document editing, formatting, and publishing.
Proactive, self-motivated, and able to work independently in a client-facing role.
Strong attention to detail and organizational skills.
Effective written and verbal communication skills.
Ability to manage multiple tasks and meet deadlines in a dynamic environment.
Team-oriented mindset with the ability to collaborate across functions.
Applies foundational CMC and regulatory concepts to support project deliverables with attention to quality and detail
Contributes to project activities with increasing autonomy, proactively seeking guidance when needed
Interprets and applies established procedures to address routine technical and regulatory questions
Demonstrates a strong learning mindset, building CMC and global regulatory knowledge (including post-approval lifecycle management) through hands-on project work
Effectively manages assigned tasks and deadlines in a remote setting, showing self-motivation and accountability
Adapts to evolving project priorities and supports multiple client needs as part of a consulting environment
Communicates clearly and collaborates with team members to ensure alignment and progress on deliverables
Supports client projects by delivering high-quality work products and developing regulatory acumen over time

Responsibilities

Support the development, authoring, and compilation of regulatory documentation related to post-approval changes and lifecycle management activities.
Assist as an authoring strategist by organizing and maintaining submission-ready documents in accordance with US FDA and global regulatory requirements (EMA, NMPA, ANVISA, PMDA, HC, TGA, etc).
Collaborate with cross-functional teams (e.g., CMC, Quality, Manufacturing, and Supply) to gather and verify required information for regulatory submissions.
Ensure documentation consistency, accuracy, and compliance with internal standards and client expectations.
Track and manage document timelines and deliverables to support regulatory milestones.
Maintain clear and proactive communication with client stakeholders while operating in a contractor capacity.
Ensures an established level of billable hours per fiscal year