Regulatory Affairs Specialist

8562-Cilag AG Legal Entity; Schaffhausen; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Johnson & Johnson in Schaffhausen, Switzerland seeks a Regulatory Affairs Specialist to provide regulatory support for the site, ensuring Swiss and international compliance. You will coordinate with Swissmedic, manage major change notices, and handle regulatory documentation across regional markets.

The role requires 4+ years in regulated environments, a relevant science degree, and strong cross-functional collaboration. This is a 2-year temporary full-time contract.

Qualifikationen

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, Engineering, Life Sciences or related field.
• Minimum 4 years of experience in Regulatory Affairs, Quality, Compliance, Manufacturing or GMP environments.
• Experience coordinating regulatory documentation and regulatory submissions.
• Knowledge of GMP requirements and pharmaceutical manufacturing processes.
• Strong organizational skills with the ability to manage multiple priorities and deadlines.
• Excellent stakeholder engagement and cross-functional collaboration abilities.
• Ability to work independently with a compliant mindset.

Aufgaben

• Act as primary Regulatory Affairs contact for site-related interactions with Swissmedic and health authorities.
• Prepare, submit and manage Swissmedic Major Change Notifications and other regulatory communications.
• Coordinate and maintain regulatory documentation including CPPs, GMP Certificates and site licenses.
• Directly handle correspondence with Swissmedic and other authorities on CPP requests and regulatory inquiries.
• Support regulatory assessments of change controls, site projects and manufacturing changes.
• Participate in strategic site projects and health authority interactions as the Regulatory Affairs representative.
• Maintain Site Master File updates, Major Change tracking and regulatory databases.
• Provide regulatory guidance and training to site functions to improve compliance awareness.

Kenntnisse

Regulatory knowledge

GMP knowledge

Stakeholder engagement

Communication skills

Attention to detail

Cross-functional collaboration

Independent work

Ausbildung

Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, Engineering, Life Sciences

Jobbeschreibung

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

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 https://www.jnj.com/.

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