Global CMC Leader, Development & Lifecycle

Karo Group, Inc.; Stockholms kommun; On-site; SEK 854,336 - 1,067,920; Full time

Benefits offered by this job

Competitive salary pack

Growth opportunities

Flexible schedule

Life-work balance

Positive work environment

Job summary

A global healthcare company is seeking a Senior Global CMC Manager in Stockholm to act as the owner of CMC Module 3 throughout the product lifecycle. The role requires proven expertise in regulatory strategies, strong collaboration with cross-functional teams, and extensive experience in variation management. You will lead strategy development while ensuring compliance with regulations, making this a key position within the team. The company promotes a diverse & inclusive environment, offering growth opportunities and a positive work culture.

Qualifications

• Strong understanding of regulatory requirements for pharmaceutical products.
• Proven expertise with full product lifecycle.
• Extensive experience in developing and executing regulatory strategies.

Responsibilities

• Act as global CMC Module 3 owner throughout the product lifecycle.
• Manage and maintain CMC documentation for global and local dossiers.
• Lead CMC strategy development for assigned products across development phases.

Skills

Regulatory requirements understanding

CMC expertise

Experience in variation management

Cross-functional collaboration

English fluency

Education

University degree in Life Sciences

Tools

Veeva RIM

Job description

A global healthcare company is seeking a Senior Global CMC Manager in Stockholm to act as the owner of CMC Module 3 throughout the product lifecycle. The role requires proven expertise in regulatory strategies, strong collaboration with cross-functional teams, and extensive experience in variation management. You will lead strategy development while ensuring compliance with regulations, making this a key position within the team. The company promotes a diverse & inclusive environment, offering growth opportunities and a positive work culture.