Regulatory Affairs Specialist (M/W/D).

Job content

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 Small Molecule (API and Solids) Department we are looking to hire an experienced

Regulatory Affairs Specialist

Responsibilities

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)
• Collaboration with customers to develop and align on 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
  
  

Qualifications

• 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.
• Supports 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 etc.)

Primary Location

Switzerland-Schaffhausen-Schaffhausen-

Organization

Cilag AG (8562)

Job Function

Regulatory Affairs

Requisition ID

2105988493W