- Entry level
- No Education
- Salary to negotiate
"Caring for the world… one person at a time” inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo.
Cilag AG in Schaffhausen belongs to the group of Johnson & Johnson pharmaceutical companies operating under the “Janssen Pharmaceutical Companies of Johnson & Johnson” trademark and manufactures high quality pharmaceutical products, active pharmaceutical ingredients (APIs) and medical devices. 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.
Reporting into the Quality Assurance API and Solids Department we are looking to hire an experienced
Regulatory Affairs Specialist (m/f)
In this regulatory function located in Schaffhausen you will perform and support the following activities to ensure regulatory filing compliance as a basis to support the business for APIs manufactured at Cilag/Janssen in Schaffhausen:
Active Substance Master File, Drug Master File, Certificate of Suitability (CEP) Submissions: Coordination and preparation for new submissions, regular updates, variations, renewals, transfers, withdrawals worldwide
Customer communication (prior and after submission of regulatory filings and/or filing updates filing)
Collaboration with customers to develop and align regulatory filing strategies and implementation plans
Coordination and preparation of responses of customer requests related to filings and or other regulatory/technical questions or questionnaires
Coordination and preparation of responses to deficiency letters or authority requests
Regulatory assessments of Change Requests and development of regulatory implementation plan
Regulatory assessment of major Non Conformances
Regulatory consultation for Quality Assurance, Production, Quality Control, Sales, Purchasing
Preparation of FDA-GDUFA (Generic Drug User Fee Amendments) applications
Regulatory support for inspections and audits
Ensure regulatory filing compliance and continued lifecycle management
Partner with Global Regulatory groups to coordinate and ensure submission of filings for US and/or other countries and/or regulatory activities for Janssen Supply Chain (JSC) products manufactured in Schaffhausen
Communicates cross-functionally and cross-company as well and presents and defends regulatory strategy and opinion to internal and external project teams.
Partner with Production, Chemical and Analytical Development, Quality Control, Quality Assurance and other departments as needed
A minimum of a Bachelor's degree with a minimum of 3+ years of relevant experience in a highly regulated environment (preferably pharmaceutical industry) or an advanced degree (MS, PhD, etc.) with a minimum of 2+ years of experience is required.
Regulatory CMC or CMC experience is preferred.
Very good knowledge of spoken and written English.
Good knowledge of spoken and written German is preferred.
Drug and/or API development experience is plus
A working knowledge of global Health Authority laws, regulations, and guidance is required.
Experience in developing regulatory strategies and an understanding of product development is preferred.
Solid understanding of relevant chemistry and/or analytics is required.
Support the establishment, maintenance and optimization of Regulatory Affairs owned or relevant processes and process related documents
A demonstrated ability to communicate regulatory requirements is required.
Ability to work in a team
Good interpersonal and verbal/written communication skills are needed.
Team and solution oriented thinking
Good organizational skills and an ability to manage multiple tasks/projects/priorities and complex systems simultaneously are needed.
Ability to demonstrate model behavior that understands what the priorities are and encourages others to drive for results
We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms and an excellent infrastructure.
If you feel attracted by this challenge and want to be part of a successful and growing organization, then please send us your online application (CV, Motivation Letter, Working References
About the company
If you’re thinking about taking your career to a place where you can be seen for the talent you bring to your work, where you’ll have a chance to be the driver of your own career, and where others share your passion for caring and success, then we invite you to explore Johnson & Johnson. BE VITAL in your career and make a unique mark. Join the approximately 129,000 men and women who work within our companies and touch the lives of more than a billion people around the world every day.