In this role, you will combine Regulatory Affairs and Quality Assurance responsibilities to support medicinal products across Switzerland and selected global markets. You will oversee regulatory submissions, marketing authorisation lifecycle management, batch release, and quality management activities while ensuring compliance with Swissmedic requirements and GDP/GMP standards. The position requires hands-on experience in both Regulatory Affairs and Quality Assurance within the pharmaceutical industry.

Start Date: September 2026 or by agreement

Duration: Unlimited - permanent position 

Place of Work: Neuchâtel 

Key Responsibilities 

  • Prepare and compile initial marketing authorisation applications (MAAs) for human medicinal products
  • Manage the lifecycle of existing marketing authorisation dossiers, including variations, renewals, and regulatory updates in accordance with Swiss and international requirements
  • Draft, review, and update clinical and non-clinical overviews, summaries, and Swiss eCTD module documentation
  • Coordinate with cross-functional teams including Medical Affairs, Quality, and Pharmacovigilance to gather, validate, and align submission data
  • Provide regulatory guidance and support regulatory strategy throughout the product lifecycle
  • Maintain regulatory information systems (e.g. RefData) and internal regulatory tracking tools
  • Keep up to date with Swissmedic requirements, ICH guidelines, and relevant regulatory developments
  • Oversee and approve batch release activities for products distributed in Switzerland
  • Maintain and continuously improve the Quality Management System (QMS) while ensuring compliance with GDP and other applicable quality standards
  • Prepare, review, and update SOPs in line with regulatory requirements and company procedures
  • Establish, review, and maintain Quality and Technical Agreements (QTAs) with suppliers and external partners
  • Support the preparation, coordination, and management of regulatory inspections where required
  • Oversee CAPA management and ensure timely implementation and documentation of corrective and preventive actions
  • Support internal and external audits, deviation management, and change control activities
  • Act as a key point of contact for quality-related matters across internal teams and external partners
  • Support the ongoing development and continuous improvement of the Quality Management System whenever required

Candidate Profile 

  • Master's degree in Life Sciences, Pharmacy, or a related scientific discipline
  • Minimum of 8 years of hands-on experience in Regulatory Affairs and Quality Assurance within the pharmaceutical industry, with a strong focus on GDP and/or GMP
  • Strong knowledge of Swissmedic regulations, Swiss eCTD dossier requirements, and ICH guidelines
  • Experience preparing clinical and non-clinical regulatory documentation
  • Proven experience managing marketing authorisation lifecycles for medicinal products
  • Hands-on experience with batch release, QMS management, quality audits, regulatory inspections, and CAPA management
  • In-depth knowledge of Swissmedic requirements, EU GDP/GMP guidelines, and international quality standards
  • Proven ability to manage multiple projects, prioritize effectively, and work independently
  • Strong interpersonal, communication, and stakeholder management skills
  • Proactive, detail-oriented, and comfortable managing multiple priorities within a highly regulated environment
  • Fluent German, French and English

Nice to have:

  • Experience with European regulatory procedures
  • Familiarity with global marketing authorisation processes (e.g. UK, Australia, Singapore, and/or Canada)
  • Experience within a CRO environment
  • Knowledge of Pharmacovigilance / Drug Safety

  • Italian language skills are considered an advantage

     

Job ID 19150