Global CMC Strategy & Lifecycle Lead

Karo Group, Inc.; Stockholms kommun; Hybrid; SEK 781,200 - 1,004,400; Full time

Benefits offered by this job

Competitive salary pack

Flexible schedule

Growth opportunities

Positive work environment

Job summary

A dynamic healthcare company in Stockholm is seeking a Senior Global CMC Manager to lead CMC management and regulatory strategies for pharmaceutical products. This role involves overseeing global CMC documentation, managing regulatory submissions, and ensuring compliance with health authority standards. Candidates should have a degree in Life Sciences, proven CMC expertise and experience with regulatory frameworks. The position offers flexible working arrangements, competitive compensation, and growth opportunities in a collaborative environment.

Qualifications

• Strong understanding of regulatory requirements for pharmaceuticals.
• Proven CMC expertise covering the full product lifecycle.
• Extensive experience in variation management and regulatory strategies.

Responsibilities

• Act as the global CMC Module 3 owner throughout the product lifecycle.
• Manage CMC components of global and local dossiers.
• Ensure timely implementation of approved CMC changes.

Skills

Regulatory requirements understanding

CMC expertise

Variation management

Pharmaceutical manufacturing processes

Cross-functional collaboration

Fluent English

Education

University degree in Life Sciences

Tools

Regulatory information systems (e.g., Veeva RIM)

Job description

A dynamic healthcare company in Stockholm is seeking a Senior Global CMC Manager to lead CMC management and regulatory strategies for pharmaceutical products. This role involves overseeing global CMC documentation, managing regulatory submissions, and ensuring compliance with health authority standards. Candidates should have a degree in Life Sciences, proven CMC expertise and experience with regulatory frameworks. The position offers flexible working arrangements, competitive compensation, and growth opportunities in a collaborative environment.