CMC Regulatory Lead – Combination Products

Biopharma Asia; Allschwil; Hybrid; CHF 180,000 - 240,000; Full time

Benefits offered by this job

Betriebliche Altersvorsorge

Job summary

Johnson & Johnson Innovative Medicine is recruiting a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products, to lead regulatory strategies for complex programs. This hybrid role based in Allschwil, Switzerland requires guiding cross-functional teams and Health Authority interactions across global programs.

The role emphasizes strategic regulatory leadership, mentorship, and extensive expertise in drug-device combination products with a strong emphasis on lifecycle management

Qualifications

• Bachelor’s degree or equivalent in a scientific, engineering, pharmaceutical, regulatory science, or related discipline is required.
• Advanced degree (Master’s, PharmD, Ph.D.) in a scientific, engineering, pharmaceutical, regulatory science, or related discipline is preferred.
• Minimum of 10 years of relevant experience in Regulatory Affairs, Quality, and/or Product Development.
• Experience in pharma/biotech/medical device, or drug-device combination products.
• Knowledge of global regulatory requirements for drug-device combinations and medical devices, including FDA and EU MDR.

Responsibilities

• Lead complex regulatory strategies for combination product programs with global scope.
• Mentor cross-functional colleagues and provide technical leadership.
• Represent regulatory affairs in external industry forums and manage Health Authority interactions.
• Drive lifecycle management and strategic decision-making across programs.

Skills

Regulatory strategy

Leadership

Mentorship

Stakeholder management

Regulatory writing

Education

Bachelor’s degree in science/engineering/pharma

Advanced degree preferred (Master’s/PhD/PharmD)

Job description

Johnson & Johnson Innovative Medicine is recruiting a Senior Principal Scientist, CMC Regulatory Affairs - Combination Products, to lead regulatory strategies for complex programs. This hybrid role based in Allschwil, Switzerland requires guiding cross-functional teams and Health Authority interactions across global programs.

The role emphasizes strategic regulatory leadership, mentorship, and extensive expertise in drug-device combination products with a strong emphasis on lifecycle management