Regulatory CMC Module 3 Dossier Development Vaccines Specialist
For our client, Janssen Vaccines & Prevention, we are looking for a Regulatory CMC Module 3 Dossier Development Vaccines Specialist.
As Regulatory CMC Module 3 Dossier Development Vaccines Specialist you will have the following responsibilities:
- Lead and execute CMC writing for clinical (CTA, IND) and is 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
We are looking for a candidate with preferably a Ph.D. and at least 3 years of relevant writing experience (module 2.3 (summary) & 3 (quality part) CMC (Chemistry, Manufacturing, Control), preferably in the field of biologics/vaccines. You have experience with authoring IND, IMPD and BLA filings and you enjoy working in a fast-paced environment. Do you have a passion for hands on regulatory submission writing? Then we are looking for you!
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: 100k|
Days of leave: 25 + 11
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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