Regulatory Affairs Specialist

Regulatory Affairs Specialist

Location: Schaffhausen

Working mode: Hybrid

Duration: Until the end of 2025 with an opportunity for a contract extension (October start)

Hours: Full-time, 40 hours per week

Pay rate range: Competitive hourly rate

roles and responsibilities

Support for the registration of pharmaceutical products in different markets with documents that are either created internally, ordered from authorities or from partner companies (e.g. GMP certificates, declarations, manufacturing licenses, Certificates of Pharmaceutical Products). 

Support of Regulatory Affairs Coordination in all areas. 

Participation in activities of the Certificates & Samples Group (C&S). 

• Compliance with the GMP, EHS and SOX requirements and guidelines associated with the respective function. 

• Compilation of the necessary documents for new product submissions.

• Processing of statements for the regulatory area. 

• Support with GMP renewals (e.g. for Brazil, Turkey). 

• Organization of notarial certification/legalization by embassies of documents. 

• Sending the original documents to the local operating companies or to regulatory affairs worldwide. 

• Communication with local operating companies and regulatory affairs.

• Direct contact with authorities regarding GMP documents and CPPs. 

• Processing of orders and coordination with authorities (Swissmedic, EMA) to create CPPs, GMP certificates and other documents. 

• Organization and creation of the necessary documents for the CPP orders 

how to succeed

• Minimum bachelor's degree in a science or technical field. 

• Proven experience in a GMP Environment and Regulatory Affairs. 

• Strong communication (verbal & written) and interpersonal skills, self-awareness, sense of urgency and flexibility required.

• Team-oriented, open-minded dynamic and highly motivated person with strong interpersonal skills. 

• Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.

benefits

This role offers a very competitive hourly rate. This contract will run until the end of 2025 with an opportunity for a contract 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. The pay rate for this role will depend on how you are paid.

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”.