Scientist I - CMC

Responsibilities

• Support the development, authoring, and compilation of regulatory documentation related to post-approval changes and lifecycle management activities.
• Aid 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.

Qualifications

• 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.