Regulatory Affairs Specialist

Regulatory Affairs Specialist - Schaffhausen 

Location: Schaffhausen, Switzerland

Hours: 40h, Hybrid way of working, on-site 3 days per week

Languages: English (fluent), German (Conversational)

Availability: Join the team from July 2024 (12 months contract)

We manufacture high quality pharmaceutical products and active pharmaceutical ingredients (APIs). Today Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all the major global markets. The Schaffhausen facility is a Johnson & Johnson strategic launch and growth site for parenteral products, and we have an impressive pipeline of new and innovative products.

The Regulatory Compliance team works with global & local cross-functional teams to support the initial submissions of J&J IM Products and to manage the life cycle of all approved licenses.

The role 

As a Regulatory Compliance Specialist, you will join a diverse team and be responsible for regulatory and compliance activities at the Schaffhausen site and drive various compliance and business improvements projects.

Due to a high number of ongoing projects combined with daily business activities, we are looking for a colleague who quickly can support the team with a focus on coordination of regulatory requests, health authorities communication and processes.

Key responsibilities:

• Support of Regulatory & Compliance Coordination in all areas, supporting the registration of pharmaceutical products in the export markets with documents that are either created internally, ordered from authorities or from partner companies (e.g. GMP certificates, manufacturing licenses, Certificates of Pharmaceutical Products)

• Processing of inquiries from health authorities and Regulatory Affairs

• Coordination of documents and communication with Local Operating Companies or to Regulatory Affairs worldwide

• Direct contact with Health Authorities regarding GMP documents

• Participation, as regulatory representative, in strategic projects for the site

• Coordinates, compiles, and manages Regulatory country specific documents required as part of the approval process for global submissions

• Supports Change Control strategy and management on site (participates in Pre-CoC meetings, supports Annual Report creation, reviews changes from regulatory perspective, etc…)

• Acts as a liaison between the global regulatory organization and business units in Schaffhausen

• Improve regulatory knowledge on site (organizing trainings, developing job aids, etc…)

• Drives a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations. Communicates critical issues to Management.

how to succeed:

• You have a Bachelor’s or Master’s Degree in a technical or science field

• You have proven experience (minimum 3 yrs) in a GMP regulated Pharma production environment, or experience in a relevant Regulatory, Compliance or Quality role (minimum 2 yrs)

• Previous experience in Pharmaceutical or Medical Devices preferable

• Strong attention to detail with high-level verbal and written communication skills, team-player, works efficiently in cross-functional and cross-company teams

• Demonstrated ability to understand priorities

• You are used to work in an GMP-environment, and have a genuine quality mindset which is shown in your daily work

• You have experience as team or project lead

• You have English (mandatory) and German (preferable)

If you are a team-oriented, open-minded dynamic and highly motivated person with strong interpersonal skills you might be the one we are looking for. For collaboration with different departments, you will need flexibility, social competence, and a reasonable degree of authority. You will take decisions independently and provide advice as needed.

Benefits

This role offers a competitive hourly rate & a supportive working environment. 

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.

https://www.jnj.ch/

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. Please apply via the link.

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”.