Regulatory Affairs Specialist

Location: Schaffhausen, Switzerland; hybrid work arrangement.

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions across Innovative Medicine and MedTech.

What you will do

• Act as the primary Regulatory Affairs contact for site-related interactions with Swissmedic and other health authorities.
• Prepare, submit, and manage Swissmedic Major Change Notifications and other regulatory communications.
• Coordinate regulatory documentation, including Certificates of Pharmaceutical Product, GMP Certificates, Manufacturing Licenses, declarations, and country-specific documents.
• Support lifecycle management, change control assessments, manufacturing changes, site projects, and regulatory impact assessments.
• Coordinate responses to regulatory requests from health authorities, local operating companies, and Global Regulatory Affairs.
• Maintain Site Master File updates, major change tracking, regulatory databases, and compliance initiatives.

Requirements

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, Engineering, Life Sciences, or a related scientific field.
• At least 4 years of experience in pharmaceutical Regulatory Affairs, Quality, Compliance, Manufacturing, or another GMP-regulated environment.
• Experience coordinating regulatory documentation and supporting regulatory submissions.
• Knowledge of GMP requirements and pharmaceutical manufacturing processes.
• Fluent English and German, both written and spoken.
• Strong organizational, communication, stakeholder engagement, compliance, and cross-functional collaboration skills.

Nice to have

• Direct experience interacting with health authorities, preferably Swissmedic.
• Experience managing CPPs, GMP Certificates, Manufacturing Licenses, or regulatory authority requests.
• Experience supporting Change Control processes and regulatory impact assessments.

Culture & Benefits

• Collaborative and inclusive working environment.
• Opportunities for learning, innovation, and professional development.
• Close collaboration with manufacturing, quality, and regulatory teams.
• Work supporting reliable product supply to patients across global markets.
• Equal opportunity employer with reasonable accommodation support available during the application, interview, and onboarding process.