Johnson & Johnson
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?
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
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.
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.
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”.