Regulatory Affairs CMC Dossier Development Specialist
Janssen Vaccines & Prevention - Leiden (Nederland)
For our client, Janssen Vaccines & Prevention, we are looking for a Regulatory Affairs CMC Dossier Development Specialist.
Do you want to be involved in getting important vaccines onto the market? Do you have experience with writing CMC Module 3 sections for biologics? This is the perfect opportunity for you!
As Regulatory Affairs CMC Module 3 Dossier Development Specialist, you are responsible for writing/driving sections of the CMC dossier and evaluating/ensuring final versions align with requirements and fulfil regulatory agency expectations.
- Lead and execute CMC writing for clinical (CTA, IND) and involved in writing marketing applications sections (BLA, MAA) for vaccines;
- Support the CMC functional subject matter experts in the development, authoring, and editing of CMC related technical data for inclusion in Modules 2 and 3 of the eCTD;
- Project leadership: independently lead CMC team meetings to resolve reviewer comments on the regulatory dossiers, execute dossier updates and meet regulatory timelines;
- Prepare, review, manage, and lead responses to CMC related questions from regulatory authorities;
- Perform reviews of dossier documents prepared by other team members for completeness, accuracy, and structure;
- Work closely with Regulatory Affairs, Analytical Development, API Process Development, Drug Product Process Development and External Stake holders to communicate document-specific timelines to team members to ensure timely deliverables.
Who we're looking for
The ideal candidate has a Ph.D. with at least 3 years of relevant regulatory Module 3 CMC writing experience in pharmaceutical biologics (vaccines is a big plus).
You have a good understanding of process validation, process development, and process characterisation within product life cycle management. Additionally, you have knowledge of regulatory requirements for biologics as well as experience authoring IND, IMPD and BLA filings. We are looking for someone with excellent written and oral communication skills, who is pro-active and able to work in a fast-paced environment.
Are you the enthusiastic team player we are looking for?
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.
In the Dossier Development and Operations Team, they are responsible for planning, writing, and reviewing the quality part of dossiers for vaccines of Janssen Vaccines & Prevention.
Additional vacancy information
|Contract||:||Temporary contract with CLS Services|
|Employment terms||:||Salary: >4300|
Days of leave: 25 + 11
See here our other employment terms for this vacancy
Project for at least 3 months for 24 hours/week
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
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