Consultant Regulatory Affairs
Janssen Vaccines & Prevention - Leiden (Nederland)
For our client, Janssen Vaccines & Prevention, we are looking for a Consultant Regulatory Affairs.
The primary responsibility is to support the regulatory activities related to vaccines in all global markets. Support CMC Teams and provide direction on the interpretation and application of global CMC regulations and guidance related to vaccines.
Additional responsibilities include
- Contribute to the preparation and editing of clinical trial and marketing applications including post-approval changes;
- Correspondence and direct interaction with Health Authorities;
- Development of product-specific regulatory strategy documents;
- Technical review and approval of master protocols, reports and other source documents.
Who we're looking for
- At least 3 years of regulatory experience with vaccines and in CMC documentation preparation (late phase INDs and IMPDs, BLAs and MAAs, and post-approval submissions);
- Strong knowledge of EU and FDA regulations is required, experience with other markets is added value;
- Experience in supporting Health Authority meetings (FDA, EMA and national agencies) preferred;
- Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required;
- Strong interpersonal, teamwork, leadership, conflict management, fast learner and negotiation skills are essential. The candidate must be able to manage and motivate people within a matrix team environment and as an individual contributor, decision maker, and leader.
Janssen Vaccines & Prevention B.V. is part of Johnson & Johnson, one of the biggest and most respected health care companies in the world. They are dedicated to bringing meaningful innovation to global health. Their teams focus on the discovery, development, manufacturing, and marketing of novel vaccines to prevent some of the most devastating and complex infectious diseases. These range from respiratory infections like respiratory syncytial virus (RSV) to human immunodeficiency virus (HIV) and pathogens of global concern, such as Ebola and COVID-19.
In this organisation, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are of crucial importance. They are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen. The offices of Janssen Vaccines & Prevention are located in Leiden, The Netherlands.
Additional vacancy information
|Contract||:||Temporary contract with CLS Services|
|Employment terms||:||Salary: >4800|
Days of leave: 36
See here our other employment terms for this vacancy
Project for at least 1 year
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
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