Yacht Life Sciences has a vacancy for a Regulatory Specialist - CMC Module 3 Dossier Development at our client Janssen Vaccines & Prevention in Leiden.
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.
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
- PhD with 3+ years relevant experience OR University degree with 6+ years relevant experience
- Regulatory CMC writing experience in pharmaceutical biologics (vaccines a plus)
- Understanding of process validation, process development, and process characterization within product life cycle management
- Proven understanding of regulatory requirements for biologic products (vaccines a plus) as well as experience authoring IND, IMPD and BLA filings
- fluency in English
- Desire and ability to learn and grow
- Excellent written and oral communication skills with the ability to work collaboratively and independently across international teams
- The ability to be a strong collaborator and great teammate
- Ability to work in a fast-paced environment and connect with different functional groups and people at multiple levels
- Strong communication and personal leadership skills, pro-active and flexible attitude, sense of urgency, excellent collaborator
We offer a challenging position which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development. This concerns a full-time secondment contract for 1 year (extension is anticipated) for minimal 24 hours a week.
We will offer a competitive benefit package in line with the seniority of the position (salary between 4500 and 6000 euro gross per 4 weeks). This role can be performed on a freelance (ZZP) base as well.
You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and to become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers, you will be able to follow courses and training via our Yacht Academy in order to keep your knowledge and skills up-to-date, i.e. boosting your career through personal and scientific growth.
Janssen Vaccines & Prevention, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to bringing meaningful innovation to global health. Their teams focus on the discovery, development, manufacture and marketing of vaccines to protect people worldwide from infectious diseases.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.