Senior CMC Regulatory Scientist (Remote)

Cardinal Health; Annapolis (MD); Remote; USD 95,000 - 136,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

Health savings account

401k savings plan

MyFlexPay access to wages

FSAs

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health is seeking a Scientist III CMC to lead regulatory strategy and execution for pre- and post-approval changes, author CMC dossiers, and collaborate with cross-functional teams. This remote role supports global regulatory filings and ensures compliance with Health Authority guidance.

The ideal candidate has Advanced CMC regulatory affairs experience, knowledge of FDA/EMA regulations, and experience with eCTD submissions.

Qualifications

• Advanced CMC regulatory affairs experience in pharma product development and quality assurance.
• Knowledge of cGMP regulations and ICH guidance.
• Proficiency with Health Authority regulations (FDA, EMA, HealthCanada).

Responsibilities

• Develop regulatory strategy and execution plans for pre-approval and post-approval changes.
• Author, review, and approve regulatory documents ensuring scientific rigor.
• Provide guidance on CMC lifecycle change assessments and submission pathways.
• Collaborate with cross-functional teams (CMC, Quality, Clinical, Supply Chain).
• Act as regulatory point of contact for client projects and maintain client relationships.
• Perform audits and remote QA support for manufacturing records and labs.
• Prepare CMC documents for INDs/NDAs/ANDAs/BLAs and other global filings.

Skills

CMC regulatory affairs

cGMP regulations

Health Authority regulations

Module 2/3 authoring

eCTD submissions

Chemistry degree

MS Office

Adobe Acrobat

Regulatory strategy

Documentation review

Education

Chemistry degree

Tools

MS Office

Adobe Acrobat

Job description

Cardinal Health is seeking a Scientist III CMC to lead regulatory strategy and execution for pre- and post-approval changes, author CMC dossiers, and collaborate with cross-functional teams. This remote role supports global regulatory filings and ensures compliance with Health Authority guidance.

The ideal candidate has Advanced CMC regulatory affairs experience, knowledge of FDA/EMA regulations, and experience with eCTD submissions.