Regulatory Affairs Specialist - Module 3 CMC

Leiden | Regulatory Affairs Specialist - Module 3 CMC | RA | BLA | MAA | CTA | IND | Vaccine | 1043155

Your new role
In the Dossier Development and Operations Team, we are responsible for planning, writing, and reviewing the quality part of dossiers for vaccines of Janssen Vaccines & Prevention. Authors/drives sections of the CMC dossier and evaluates/ensures that final versions align with requirements and fulfill regulatory agency expectations. Supports the technical functions in the development of responses to health authority questions related to clinical trials and marketing applications. Evaluates and ensures the completeness, accuracy, and compliance of data for all regulatory submissions. Ensures all dossiers are delivered in a timely manner.

  • 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 Stakeholders to communicate document-specific timelines to team members to ensure timely deliverables

What you'll need to succeed
To be successful in this role you hold a PhD degree with 3+ years relevant experience or a MSc degree with 6+ years relevant experience . Preferably you have Regulatory CMC writing experience in pharmaceutical biologics (vaccines a plus). You have a solid understanding of process validation, process development, and process characterization within product life cycle management. And a proven understanding of regulatory requirements for biologic products (vaccines a plus) as well as experience authoring IND, IMPD and BLA filings.

As a person you’re a strong collaborator and great teammate with a desire and ability to learn and grow. You have the ability to work in a fast-paced environment and connect with different functional groups and people at multiple levels and you show strong communication and personal leadership skills, pro-active and flexible attitude. Last but not least you have excellent written and oral communication skills with the ability to work collaboratively and independently across international teams

Your new company
Janssen Vaccines & Prevention, formerly Crucell, is dedicated to bringing meaningful innovation to global health. Their teams focus on the discovery, development, manufacture and marketing of vaccines and antibodies to protect people worldwide from infectious diseases. In the Janssen organization, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. To strengthen the team, Janssen is continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value.

What you'll get in return
Hays Detachering/Contracting | This is a project that will start with a contract for 12 months via Hays. At this position, you will get a competitive salary/rate and in case of secondment your travel expenses are covered.

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
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Job Type
Life Sciences
based on experience + travel expenses

Talk to a consultant

Talk to Ricardo Vos, the specialist consultant managing this position, located in Amsterdam
Hays Amsterdam, H.J.E. Wenckebachweg 210

Telephone: 0615878909

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