Description

You will serve as the CMC Product Lead, managing regulatory milestones throughout the product lifecycle.

Responsibilities

• Lead CMC compliance activities including gap analysis, CMC comparison, and validation for quality reports.
• Author assessment reports, Part 2/Expert reports for dossiers, and CMC documentation (Modules 1, 2, and 3) for post-approval supplements, annual reports, and registration renewals.
• Execute global regulatory strategies by assessing CMC changes and identifying global regulatory requirements and risks.
• Review quality documents including reformulation studies, process validations, stability studies, and impurity qualifications.
• Identify, communicate, and escalate potential regulatory risks while proposing mitigation strategies.

Required Skills

• Experience performing Gap Analysis and CMC comparison.
• Technical expertise reviewing process validations, particle size method implementation, and stability indicating methods.
• Experience with impurity qualification, assay methods, sterile filter testing, and preservative effectiveness testing.
• Ability to manage CMC documentation for lifecycle management and health authority responses.
• Strong understanding of regulatory guidelines and applications.
• Proven ability to manage project deliverables and meet agreed SLAs.
• Bachelor's or master's degree in science, engineering, or a related field.

Preferred Skills

• Experience in pharmaceutical, vaccine, or biological product regulatory affairs.
• Marketing authorization and project management experience.

Key Skills

Education

ANY GRADUATE