Regulatory Affairs Specialist

7 days ago

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

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Indivior, a global specialty pharmaceutical company. As a key member of our R&D CMC team, you will be responsible for writing, reviewing, and approving Module 3 documentation, supporting the development and maintenance of new and existing dossiers for projects from Phase 1 inception through to the post-approval phase.

Key Responsibilities
  • Support the creation and maintenance of chemistry, manufacturing, and controls information in Module 3 dossiers, including Module 2.3 QOS, covering drug substance and drug product.
  • Write, review, and approve regulatory submission documents and prepare responses to questions raised by Healthcare Authorities.
  • Support CMC changes in response to Regulatory Intelligence and CMC aspects of Change Control for existing Licenses.
  • Take ownership of projects assigned to you, ensuring project milestones are delivered on time and to plan.
  • Maintain a strong working knowledge of ICH guidelines, EMA, and FDA guidance for industry and local regulations, applying these principles in all aspects of your role.
  • Actively participate in Module 3 strategy and planning meetings, risk assessments, and stakeholder interactions to leverage your technical and regulatory expertise and insight, to drive the right decisions at the right time and mitigate risk.
  • Liaise with 3rd parties, global regulatory, local regulatory, QA, Supply, and other relevant functions to support delivery of Module 3.
  • Proactively contribute to the continuous improvement of the CMC function with respect to new technologies and processes.
Requirements
  • Education: Bachelor's degree or higher in a relevant field, such as Chemistry or a related science.
  • Experience: 5-10+ years' experience of scientific writing and/or reviewing Module 3 dossiers in CTD format.
  • Computer Skills: Proficient in basic computer applications such as Microsoft Word, Outlook, PowerPoint, and Excel.
  • License/Certifications: Not applicable.
Preferred Qualifications
  • 2.1 or 1st class degree preferred.
  • Experience in the following areas is beneficial: Drug substance requirements, global market requirements, especially US, Europe, Canada, and use of Veeva, D2, or similar document management systems.
Benefits
  • 25 days holiday plus public holidays.
  • Flexible working with core hours of 10am-3pm and up to 2 days working from home/week for office-based roles.
  • Paid Volunteer Time Off and 10% company pension.
  • EAP service including Legal, Health, and Wellbeing support and optional Health Insurance with BUPA.
  • Company Death in Service and Payment Protection Insurance and 3 Celebratory days.
  • Access to a platform for discounts on gym membership, shopping, and holidays.
Travel

Little to no travel required.

Compliance Obligations
  • Always act with honesty and integrity.
  • Risk IQ: Know what policies apply to your role and function and adhere to them.
  • Speak Up: If you see something, say something.

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