Regulatory Affairs Scientist Lead

3 weeks ago


Hull, Kingston upon Hull, United Kingdom Indivior Full time
Job Summary

We are looking for an experienced Regulatory Affairs Scientist Lead to join our R&D CMC team in Hull, UK. As a key member of the team, you will play a critical role in developing and maintaining new and existing dossiers for projects from Phase 1 inception through to the post-approval phase.

About the Role

The successful candidate will have experience in scientific writing and reviewing Module 3 dossiers in CTD format. They will be responsible for creating and maintaining chemistry, manufacturing and controls information, as well as writing, reviewing and approving regulatory submission documents.

Key Responsibilities
  • Supporting dossier development: The role involves supporting the creation and maintenance of Module 3 dossiers, including QOS, covering drug substance and drug product.
  • Document preparation: The successful candidate will write, review and approve regulatory submission documents and prepare responses to questions raised by Healthcare Authorities.
  • Project ownership: They will take ownership of assigned projects, ensuring project milestones are delivered on time and to plan.
Requirements
  • Education: A Bachelor's degree or higher in Chemistry or a related science.
  • Experience: 5-10+ years' experience in scientific writing and/or reviewing Module 3 dossiers in CTD format.
Benefits
  • Competitive salary: £60,000 - £80,000 per annum, depending on experience.
  • Flexible working: Core hours are 10am-3pm, and we offer up to 2 days working from home/week for office-based roles.
  • Annual leave: 25 days holiday plus public holidays.
Guiding Principles

Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.



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