CMC Regulatory Lead – Global Pharma Development (Hybrid)

Kenvue-1; Helsingborgs kommun; Hybrid; SEK 762,112 - 1,088,732; Full time

Job summary

Kenvue-1 is looking for a Regulatory Affairs CMC Manager in Helsingborg, Sweden to provide end-to-end oversight for Module 3/CMC new product development and life cycle management. The candidate will lead regulatory strategy development for new products, collaborating with various cross-functional teams to ensure compliance and operational excellence.

Successful applicants will possess a relevant Bachelor's Degree, have over 10 years of experience in regulatory affairs, and demonstrate strong project and people management skills.

Qualifications

• 10+ years experience in regulatory affairs or pharmaceutical product development.
• Expertise in regulatory classifications, especially for medicinal products and medical devices.
• Knowledge of global regulatory frameworks for pharmaceutical development.

Responsibilities

• End-to-end responsibility for Module 3/CMC new product development.
• Lead regulatory CMC strategy development in new product projects.
• Create and maintain partnerships with Regulatory Affairs and cross-functional teams.

Skills

Regulatory affairs experience

Pharmaceutical product development

Project management

Collaboration

Strong ownership

Proficiency in English

Education

Bachelor's Degree or higher

Job description

Kenvue-1 is looking for a Regulatory Affairs CMC Manager in Helsingborg, Sweden to provide end-to-end oversight for Module 3/CMC new product development and life cycle management. The candidate will lead regulatory strategy development for new products, collaborating with various cross-functional teams to ensure compliance and operational excellence.

Successful applicants will possess a relevant Bachelor's Degree, have over 10 years of experience in regulatory affairs, and demonstrate strong project and people management skills.