Regulatory Affairs Specialist
3 weeks ago
Indivior PLC Overview
At Indivior PLC, we are a global specialty pharmaceutical company dedicated to developing medicines to treat substance use disorders and serious mental illnesses. Our team is committed to making a positive impact on patients' lives by delivering high-quality products and services.
Salary: £55,000 - £70,000 per annum
Job Summary:
We are seeking an experienced Lead Regulatory Scientist to join our Module 3 Dossier Development function in Hull, UK. As a key member of our R&D CMC team, you will be responsible for writing, reviewing, and approving regulatory submission documents and preparing responses to questions raised by Healthcare Authorities.
Key Responsibilities:
- Support the creation and maintenance of chemistry, manufacturing, and controls information in Module 3 dossiers, including Module 2.
- Write, review, and approve regulatory submission documents and prepare responses to questions raised by Healthcare Authorities.
- 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.
- Liaise 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.
Benefits:
- 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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