Remote CMC Regulatory Scientist – Senior

Cardinal Health; Juneau (AK); Remote; USD 95,000 - 136,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Paid time off

HSA

401k plan

MyFlexPay access

FSAs

Disability coverage

Work-Life resources

Parental leave

Wellness programs

Job summary

Cardinal Health seeks a Scientist III CMC for remote, full-time work to develop regulatory strategies, author high-quality dossiers, and manage lifecycle activities across global markets. The role requires deep knowledge of FDA/EMA regulations, cGMP, and eCTD submissions, with leadership of junior staff and cross-functional collaboration.

Responsibilities include drafting and reviewing CMC documents, conducting audits, and supporting regulatory strategy with clients.

Qualifications

• Advanced CMC regulatory affairs experience in pharmaceutical product development and quality assurance.
• Knowledge of cGMP regulations and ICH guidance.
• Proficiency with Health Authority regulations (FDA, EMA, Health Canada, etc.)
• Module 2 and Module 3 authoring experience is a plus
• Experience with writing global regulatory applications in eCTD format
• MS/BS in Chemistry, Analytical Chemistry, or related life sciences
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Proficiency with Adobe Acrobat for document editing, formatting, and publishing.
• Understanding and application of scientific principles and techniques used in pharmaceutical product development
• Strong attention to detail and organizational skills.

Responsibilities

• Develop regulatory strategy and execution plan for pre-approval, post-approval changes, and lifecycle management activities.
• Serve as an author strategist, defining document structure, content strategy, and submission approach for complex regulatory dossiers.
• Author, review, and approve high-quality regulatory documents (e.g., supplements, variations, responses to health authority queries) ensuring scientific and regulatory rigor.
• Provide strategic input on CMC and lifecycle change assessments, including regulatory risk evaluation and submission pathways.
• Collaborate with cross-functional stakeholders (CMC, Quality, Clinical, Supply Chain) to drive alignment on regulatory strategy and ensure accurate and complete submission content.
• Act as a primary regulatory point of contact for assigned client projects, providing guidance and maintaining strong client relationships in a consultant role.
• Performs cGMP audits of active pharmaceutical ingredient and drug product manufacturers, and contract laboratories, domestically and internationally
• Perform remote quality assurance support – auditing of manufacturing production and testing records; protocols and data sets
• Authors and reviews CMC documents for INDs, NDAs, ANDAs, BLAs, Drug Master Files, and other similar global regulatory applications
• Manages assembly of global regulatory applications including extraction of pertinent CMC information from global regulatory databases
• Mentor and provide day-to-day guidance to junior regulatory staff, supporting their technical development in regulatory strategy, authoring, and submission processes.
• Review, edit, and provide feedback on work produced by junior team members, ensuring accuracy, consistency, and compliance with regulatory and client standards.
• Promote best practices in document preparation, quality, and regulatory compliance across the team.
• Maintains good client relationships
• Ensures an established level of billable hours per fiscal year

Skills

CMC regulatory

FDA/EMA knowledge

eCTD authoring

MS/BS in Chemistry

Office suite

Adobe Acrobat

Regulatory strategy

Attention to detail

Education

MS/BS in Chemistry

Tools

MS Office

Adobe Acrobat

Job description

Cardinal Health seeks a Scientist III CMC for remote, full-time work to develop regulatory strategies, author high-quality dossiers, and manage lifecycle activities across global markets. The role requires deep knowledge of FDA/EMA regulations, cGMP, and eCTD submissions, with leadership of junior staff and cross-functional collaboration.

Responsibilities include drafting and reviewing CMC documents, conducting audits, and supporting regulatory strategy with clients.