Regulatory Affairs Specialist

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. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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