Hybrid: CMC Regulatory Lead for Drug-Device Combinations

Johnson & Johnson Co.; Allschwil; Hybrid; CHF 150,000 - 230,000; Full time

Benefits offered by this job

Hybrid work environment

Job summary

Johnson & Johnson in Allschwil, Switzerland, seeks a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products. This hybrid role focuses on leading regulatory strategies for complex combination product programs and providing expert guidance on global requirements.

You will support cross-functional teams, mentor colleagues, and interact with Health Authorities to drive successful product development and lifecycle management.

Qualifications

• Bachelor’s degree or equivalent in a scientific, engineering, pharmaceutical, regulatory science, or related discipline.
• Advanced degree (Master’s, PharmD, Ph.D.) in a scientific, engineering, pharmaceutical, regulatory science, or related discipline is preferred.
• Minimum 10 years of experience in Regulatory Affairs, Quality, and/or Product Development.
• Experience supporting global regulatory submissions, Health Authority interactions, and device-related CMC submission content.
• Knowledge of global regulatory requirements for drug-device combination products and medical devices.

Responsibilities

• Lead global regulatory strategies for clinical, marketing, and lifecycle submissions for combination products.
• Provide interpretation of regulatory requirements for drug-device combinations and related device parts.
• Lead regulatory assessments for manufacturing, device, and lifecycle changes with global impact.
• Mentor regulatory and cross-functional colleagues; coach on regulatory strategy and policy.
• Represent CMC RA in Health Authority interactions and external regulatory activities.

Skills

Regulatory Affairs

Quality

Product Development

Strategic Thinking

Regulatory Writing

Leadership

Stakeholder Management

Education

Bachelor’s degree in scientific/engineering/pharmaceutical/regulatory field

Advanced degree (Master’s, PharmD, Ph.D.) preferred

Job description

Johnson & Johnson in Allschwil, Switzerland, seeks a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products. This hybrid role focuses on leading regulatory strategies for complex combination product programs and providing expert guidance on global requirements.

You will support cross-functional teams, mentor colleagues, and interact with Health Authorities to drive successful product development and lifecycle management.