Dossier Development Expert
3 weeks ago
About Us
As a global specialty pharmaceutical company, Indivior PLC is committed to delivering innovative solutions for patients with substance use disorders and serious mental illnesses. Our mission is to improve patient outcomes through the development and delivery of high-quality products and services.
Job Description:
This role involves supporting the creation and maintenance of chemistry, manufacturing, and controls information in Module 3 dossiers, including Module 2. The successful candidate will have a strong working knowledge of ICH guidelines, EMA, and FDA guidance for industry and local regulations, and will be able to apply these principles in all aspects of their role.
Main Responsibilities:
- Writing, reviewing, and approving regulatory submission documents and preparing responses to questions raised by Healthcare Authorities.
- Supporting CMC changes in response to Regulatory Intelligence.
- Taking ownership of projects assigned to you, ensuring project milestones are delivered on time and to plan.
- Liaising with 3rd parties, global regulatory, local regulatory, QA, Supply, and other relevant functions to support delivery of Module 3.
Requirements:
- Bachelor's degree or higher in Chemistry or related relevant science.
- 5-10+ years' experience of scientific writing and/or reviewing Module 3 dossiers in CTD format.
- Proficient in basic computer applications such as Microsoft Word, Outlook, PowerPoint, Excel.
What We Offer:
- Competitive salary: £55,000 - £70,000 per annum.
- 25 days holiday plus public holidays.
- Flexible working; core hours are 10am-3pm, and we offer up to 2 days working from home/week for office-based roles.
- Paid Volunteer Time Off.
- 10% company pension.
- EAP service including Legal, Health, and Wellbeing support.
- Optional Health Insurance with BUPA.
- Company Death in Service and Payment Protection Insurance.
- Access to platform for discounts on gym membership, shopping, holidays.
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