Regulatory Affairs Specialist

Quality

Quality Systems

Professional

Schaffhausen, Switzerland

We are searching for the best talent for a Regulatory Affairs Specialist
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Schaffhausen, Switzerland

Temporary full-time position (2-year contract)

We are looking for a Regulatory Affairs Specialist to join our team in Schaffhausen, Switzerland.

In this role, you will provide regulatory support to the Schaffhausen manufacturing site and help ensure compliance with Swiss and international regulatory requirements. Acting as a key point of contact for regulatory activities, you will support health authority interactions, lifecycle management activities, regulatory documentation, and site projects that are critical to maintaining compliance and continuity of supply.

Working closely with local site functions, Global Regulatory Affairs, and health authorities, you will help ensure timely execution of regulatory commitments and effective management of regulatory requirements across the site.

In this role, you will serve as a primary Regulatory Affairs contact for site-related regulatory activities and support interactions with Swiss medic and other health authorities.

You will coordinate regulatory documentation, support lifecycle management activities, and provide regulatory guidance for site projects and manufacturing changes. The role also includes helping ensure regulatory commitments are met and that site activities remain aligned with applicable regulatory requirements.

• Acting as a primary Regulatory Affairs contact for site-related interactions with Swiss medic and other health authorities
• Preparing, submitting, and managing Swiss medic Major Change Notifications and other regulatory communications
• Coordinating, preparing, maintaining, and issuing regulatory documentation, including:
• Certificates of Pharmaceutical Product (CPPs) for Switzerland and EU markets
• GMP Certificates
• Manufacturing Licenses
• Regulatory declarations and statements
• Country-specific regulatory documents
• Managing direct correspondence with Swiss medic regarding CPP requests, GMP Certificates, Manufacturing Licenses, regulatory inquiries, and site-related activities
• Coordinating responses to regulatory requests from Health Authorities, Local Operating Companies, and Global Regulatory Affairs organizations
• Supporting regulatory assessments of change controls, site projects, manufacturing changes, and business initiatives
• Participating as the Regulatory Affairs representative in strategic site projects and health authority interactions
• Maintaining and supporting site regulatory documentation, including Site Master File updates, Major Change tracking, and regulatory databases
• Providing regulatory guidance to site functions and helping improve regulatory awareness through training, job aids, and compliance initiatives
• Contributing to initiatives that strengthen regulatory compliance, efficiency, and regulatory processes

We are looking for someone who combines regulatory knowledge, strong organizational skills, and the ability to work effectively across a regulated manufacturing environment.

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, Engineering, Life Sciences, or another relevant scientific field

• Minimum 4 years of experience in the pharmaceutical industry within 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
• Strong organizational skills with the ability to manage multiple priorities and deadlines
• Strong stakeholder engagement and cross-functional collaboration skills
• Ability to work independently while maintaining a compliance-focused approach
• Strong communication and interpersonal skills
• High attention to detail and quality mentality
• Ability to influence and collaborate across functions
• Strong sense of ownership and accountability
• Continuous improvement approach
• Ability to prioritize effectively in a dynamic environment

• Experience interacting directly with Health Authorities, preferably Swiss medic
• Experience managing Certificates of Pharmaceutical Product (CPPs), GMP Certificates, Manufacturing Licenses, or regulatory authority requests
• Experience…