Compliance / Regulatory Specialist

Senior Compliance / Regulatory Specialist 

Location:   Schaffhausen, Switzerland (hybrid)

Duration: 8 months

Hours: 70/80% or 100 % 

Other: English essential, German, desirable, pharma background essential

Imagine your next step, working for Johnson & Johnson - Janssen / Cilag AG as  a Senior Compliance Specialist located in Schaffhausen. 

With a workforce of roughly 1,200 people, Cilag AG is one of the major producers of the Swiss pharmaceutical industry and one of the most important employers in the Schaffhausen region. Perhaps you too will soon be joining their number?

Main responsibilities

• Creation and maintenance of the Master Files Pharma & API site

• Coordination and notification of significant changes to Swissmedic according to Art. 41 Para. 2 AMBO

• CoC assessor for significant changes in accordance with Art. 41 Para. 2 AMBO

• Process Owner for the Supplier Qualification Process for Indirect Materials and service providers

• Support of Regulatory Affairs Coordination in all areas

• Support for registrations of pharmaceutical products in the Export markets with documents, either created internally, at authorities or ordered from partner companies (e.g. GMP certificates, Manufacturing licences, Certificates of Pharmaceutical Products)

how to succeed

Qualifications / Experience / Skills:

• Comply with GMP, EHS and SOX requirements and policies associated with the respective function

• Creation and maintenance of the SMF of Cilag AG

• Reviewer and local approver for the initiation of indirect materials and

• Reviewer and approver of site workflows for Indirect Materials

• Support of orders and coordination with authorities (Swissmedic, EMA) for the creation of CPPs, GMP Certificates and other documents

• Support for the organization and preparation of the necessary documents

  for the CPP orders

• Compilation of the necessary documents for new products, handling inquiries from authorities and regulatory affairs

• Support paper-based inspections, participation in inspection preparations and back office

• Sending the original documents to the Local Operating Companies or to Regulatory affairs worldwide.

• Archiving of documents

• Communication with Local Operating Companies and Regulatory Affairs

• Direct contacts to authorities regarding GMP documents and support at CPP

Essential:

Previous experience within pharmaceutical, regulatory and compliance 

What’s in it for you?  

As the biggest health company in the world, we find it important to put the needs and well-being of our customers and employees first. Our recipe for success consists of crafting an inclusive work environment where everybody feels welcome and respected. 

At Johnson & Johnson, we blend heart, science and ingenuity to profoundly change the trajectory of health for humanity.  

https://www.cilag.ch

benefits

This role offers a very competitive hourly rate. This contract will run for 8 months and has a strong chance of extension. 

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson. 

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. 

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.