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Johnson & Johnson

Regulatory Dossier Developer

Posted May 31, 2022
Job ID: JJJP00011183
Location
Leiden
Hours/week
40 hrs/week
Timeline
11 months
Starts: Jun 13, 2022
Ends: May 1, 2023
Payrate range
Unknown
Application Deadline: Jun 13, 2022 12:00 AM

Leiden, Netherlands, 40h, hybrid 

 

Johnson & Johnson Worksense is responsible for finding, engaging, and contracting talent for the Johnson & Johnson contingent workforce.

 

We are currently recruiting a Regulatory Dossier Developer to join our contingent workforce in Janssen in Leiden for an initial one-year contract.

 

 

As a Regulatory Dossier Developer, you are responsible to:

 

  • Lead and execute CMC (Chemistry, Manufacturing, Control) writing for clinical (CTA, IND) and be 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.

 

 

To be successful in this role you have:

 

  • PhD with 3+ years relevant experience OR University degree with 6+ years relevant experience
  • Regulatory CMC writing experience in pharmaceutical biologics (vaccines a plus) preferred
  • 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
  • Excellent written and oral communication skills with the ability to work collaboratively and independently across international teams
  • 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, and a sense of urgency 



 

If you meet our requirements and are interested in hearing more about our Regulatory Dossier Developer role, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!


 

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

 

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

 

That is why we in the Netherlands are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

 

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!



 

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