Regulatory Affairs Specialist

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 .

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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
...