Regulatory Affairs Specialist

jj; Schaffhausen; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

Johnson & Johnson in Schaffhausen, Switzerland is seeking a Regulatory Affairs Specialist to support regulatory compliance for the site and global interfaces. You will coordinate Swissmedic activities, prepare change notifications, and manage regulatory documentation such as CPPs, GMP certificates, and licenses.

Working with local functions, Global Regulatory Affairs, and health authorities, you will help ensure timely regulatory commitments and compliance with Swiss and international

Qualifikationen

• Bachelor’s or Master’s degree in a relevant scientific field.
• Minimum 4 years of experience in Regulatory Affairs or GMP-regulated environment.
• Experience coordinating regulatory documentation and submissions.

Aufgaben

• Act as primary Regulatory Affairs contact for site-related interactions with Swissmedic and other health authorities.
• Preparing, submitting, and managing Swissmedic Major Change Notifications and other regulatory communications.
• Coordinating, preparing, maintaining, and issuing regulatory documentation (CPPs, GMP Certificates, Manufacturing Licenses).
• Managing correspondence with Swissmedic regarding CPP requests, GMP Certificates, and regulatory inquiries.
• Coordinating responses to regulatory requests from Health Authorities and Global Regulatory Affairs teams.

Kenntnisse

GMP knowledge

Regulatory affairs

Cross-functional collaboration

Stakeholder engagement

Communication

Organizational skills

Attention to detail

Problem solving

Change control

Independent working

Ausbildung

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

Jobbeschreibung

Job Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Schaffhausen, Switzerland

Job Description:

We are searching for the best talent for a Regulatory Affairs Specialist.

Location:

Schaffhausen, Switzerland

Contract Type:

Temporary full-time position (2-year contract)

Purpose

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.

You will be responsible for

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

Key responsibilities include:

• Acting as a primary Regulatory Affairs contact for site-related interactions with Swissmedic and other health authorities
• Preparing, submitting, and managing Swissmedic 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 Swissmedic 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

Qualifications / Requirements

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

Education

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

Experience

• 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 & Skills

• 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

Preferred Qualifications

• Experience interacting directly with Health Authorities, preferably Swissmedic
• Experience managing Certificates of Pharmaceutical Product (CPPs), GMP Certificates, Manufacturing Licenses, or regulatory authority requests
• Experience supporting Change Control processes and regulatory impact assessments

Language Requirements

• Fluent English and German, both written and spoken
• Ability to communicate effectively with local authorities and Global Regulatory Affairs organizations
• Strong written communication skills for preparation of regulatory correspondence, submissions, and health authority responses
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity

What we offer

We offer a collaborative and inclusive environment where learning, innovation, and professional development are encouraged.

In this role, you will have the opportunity to work closely with manufacturing, quality, and regulatory teams while supporting regulatory activities that contribute to the reliable supply of products to patients across global markets.

Our commitment to inclusion

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation is powered by bringing together people with different backgrounds, experiences, and perspectives.

We are proud to be an equal opportunity employer and welcome applications from qualified candidates of all backgrounds.

If you require a reasonable accommodation during the application, interview, or onboarding process, support is available. Please let us know how we can help.

#LI-Hybrid

Required Skills:

Preferred Skills:

• Analytical Reasoning
• Business Alignment
• Business Behavior
• Coaching
• Collaboration
• Communication
• Compliance Management
• Data Compilation
• Data Quality
• Data Savvy
• Document Management
• Problem Solving
• Quality Auditing
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Services
• Quality Standards
• Systems Analysis
• Training People