Regulatory Affairs Specialist

Johnson Johnson; Schaffhausen; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

Johnson & Johnson in Schaffhausen, Switzerland, seeks a Regulatory Affairs Specialist to support the site with Swiss and international regulatory compliance. You will act as main contact for regulatory activities and drive timely submissions and health authority interactions.

Required are a scientific degree and 4+ years in regulatory/regulatory-compliance roles, with strong knowledge of GMP and cross-functional collaboration. This role is a 2-year temporary contract at our Schaffhausen site.

Qualifikationen

• Bachelor's or Master's in a scientific field; GMP knowledge preferred.
• Minimum 4 years in Regulatory Affairs or GMP-regulated roles.
• Experience coordinating regulatory documents and submissions.

Aufgaben

• Act as primary Regulatory Affairs contact for site regulatory needs.
• Prepare and submit Swissmedic notifications and regulatory communications.
• Coordinate regulatory documents: CPPs, GMP certificates, licenses.
• Manage correspondence with Swissmedic and health authorities.
• Support site regulatory databases and training to improve compliance.

Kenntnisse

GMP knowledge

Regulatory affairs

Stakeholder engagement

Cross-functional collaboration

Attention to detail

Ausbildung

Bachelor's or Master's in Pharmacy/ Chemistry/ Biology/ Engineering

Jobbeschreibung

Company Overview

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual.

We respect the diversity and dignity of our employees and recognize their merit.

Job Information

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.

Key Responsibilities

• 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

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

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