Senior Scientist, CMC Regulatory Affairs - Combo Products

Johnson & Johnson Co.; Allschwil; Hybrid; CHF 180,000 - 260,000; Full time

Job summary

Johnson & Johnson in Allschwil, CH is seeking a Distinguished Scientist, CMC Regulatory Affairs – Combination Products to lead global regulatory strategies for complex drug-device programs. You will drive policy and strategy across regions and mentor teams to ensure compliant submissions and lifecycle management.

This hybrid role requires deep regulatory expertise, strong leadership, and collaboration with cross-functional partners to advance innovative medicine and medtech initiatives.

Qualifications

• Bachelor’s degree in biological, pharmaceutical, chemical, engineering, regulatory science, medical device, or other relevant field is required.
• 12+ years of relevant experience in pharma, biotech, or medical device industries; inclusive of post-graduate education.
• Demonstrated expertise in drug-device regulatory strategies and global CMC submissions.

Responsibilities

• Lead innovative CMC regulatory strategies for complex combination products across regions.
• Represent J&J in external regulatory forums and benchmark against industry practices.
• Provide strategic consultation for drug-device programs and risk mitigation.
• Mentor colleagues and strengthen regulatory capability across teams.

Skills

Regulatory strategy

CMC regulatory affairs

Drug-device combinations

Global submissions

Stakeholder management

Regulatory intelligence

Education

Bachelor's degree in a relevant scientific field

Job description

Johnson & Johnson in Allschwil, CH is seeking a Distinguished Scientist, CMC Regulatory Affairs – Combination Products to lead global regulatory strategies for complex drug-device programs. You will drive policy and strategy across regions and mentor teams to ensure compliant submissions and lifecycle management.

This hybrid role requires deep regulatory expertise, strong leadership, and collaboration with cross-functional partners to advance innovative medicine and medtech initiatives.