Regulatory Affairs Specialist

3 weeks ago


Hull, Kingston upon Hull, United Kingdom Indivior PLC Full time

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.


  • Hull, Kingston upon Hull, United Kingdom Indivior Full time

    Job SummaryWe 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 RoleThe successful candidate will have...


  • Hull, Kingston upon Hull, United Kingdom Indivior Full time

    Indivior, a global specialty pharmaceutical company, is seeking an experienced Scientific Documentation Specialist to join its Regulatory Affairs team in Hull, UK. This is a rewarding opportunity for individuals who thrive in fast-paced environments and have a strong background in scientific writing and regulatory affairs.The successful candidate will...


  • Hull, Kingston upon Hull, United Kingdom Reckitt Benckiser LLC Full time

    Senior Associate, NutritionThe Estimated Salary for this role is around $80,000 - $110,000 per year. This figure is based on the location of Slough and the typical salary range for a senior associate in a similar position.We are Reckitt, home to some of the world's best-loved and trusted hygiene, health, and nutrition brands. Our goal is to make access to...


  • Hull, Kingston upon Hull, United Kingdom Smith & Nephew Full time

    Job DescriptionThis is a diverse role that requires strong relationship-building, networking, multitasking, and influencing skills. You will work closely with R&D, Marketing, Operations, Quality, and Regulatory Affairs teams to ensure that NPD programs are delivered on time, within budget, and to the required quality standards.ResponsibilitiesLead...


  • Hull, Kingston upon Hull, United Kingdom Levitate Recruitment - Accountancy and Insolvency Recruitment Specialists Full time

    Levitate Recruitment - Accountancy and Insolvency Recruitment Specialists is currently recruiting for a Senior Insolvency Administrator to join their team. As a Senior Insolvency Administrator, you will be responsible for managing a caseload of mainly Liquidations and Administrations from case progression through to closure.The ideal candidate will have...


  • Hull, Kingston upon Hull, United Kingdom Levitate Recruitment - Accountancy and Insolvency Recruitment Specialists Full time

    Key ResponsibilitiesThe successful candidate for the position of Insolvency Administrative Support will be responsible for accompanying IPs to initial meetings, performing asset realisations, identifying potential assets and issues, and preparing Section 98 reports and Statement of Affairs. The firm offers excellent career progression opportunities for the...


  • Hull, Kingston upon Hull, United Kingdom Petroplan Full time

    Job Title: Process Control SpecialistWe are seeking an experienced Process Control Specialist to join our team at a major Petrochemicals Manufacturing client's Hull base. As a key member of our staff, you will work on continuous refinery/chemical processes with Honeywell TPS/Experion control systems and FSC/SM safety systems.The position offers a full staff...


  • Hull, Kingston upon Hull, United Kingdom Levitate Recruitment - Accountancy and Insolvency Recruitment Specialists Full time

    Levitate Recruitment - Accountancy and Insolvency Recruitment Specialists is seeking a highly skilled Senior Insolvency Administrator to join their team. As a Senior Insolvency Administrator, you will be responsible for managing a caseload of mainly Liquidations and Administrations from case progression through to closure, and identifying potential assets...


  • Hull, Kingston upon Hull, United Kingdom Levitate Recruitment - Accountancy and Insolvency Recruitment Specialists Full time

    We are seeking an experienced Senior Insolvency Administrator to join our team at Levitate Recruitment - Accountancy and Insolvency Recruitment Specialists. As a Senior Insolvency Administrator, you will play a key role in managing a caseload of mainly Liquidations and Administrations from case progression through to closure.The successful candidate will...


  • Hull, Kingston upon Hull, United Kingdom Health Jobs UK Full time

    About CHCP CICCity Health Care Partnership CIC (CHCP CIC) is an independent, co-owned Community Interest Company providing high quality local health and care services at several sites across Hull and East Yorkshire.We are a co-owned, socially responsible business commissioned by the NHS and local authorities. Our profits are re-invested into our services,...


  • Hull, Kingston upon Hull, United Kingdom Pontoon Full time

    Ecological Clerk of Works OpportunityPontoon is seeking an experienced Ecological Clerk of Works to join their team on a Fixed Term Contract basis. This role will contribute to the construction phase of a high voltage direct current (HVDC) electrical project.Project Overview:EGL2 is a 2GW HVDC electrical 'superhighway' cable link between Peterhead in...


  • Hull, Kingston upon Hull, United Kingdom Sanctuary Personnel Ltd Full time

    About the Role:We are looking for a dedicated and experienced Mental Health Support Specialist to join our High Needs Team. As a key member of the team, you will be responsible for providing comprehensive support and assistance to individuals with mental health challenges and learning disabilities.The ideal candidate will have a qualification in social work...


  • Hull, Kingston upon Hull, United Kingdom Cranswick Country Foods PLC Full time

    Career opportunities abound in the food industry, and Cranswick Country Foods PLC is at the forefront of innovation and growth. Our Food Technical Graduate Programme offers a chance to join a dynamic team and contribute to the future of food production.About the RoleAs a Product Quality and Safety Specialist, you will play a vital role in safeguarding...


  • Hull, Kingston upon Hull, United Kingdom Bilfinger Full time

    Key ResponsibilitiesThe successful Quality Assurance Manager will be responsible for:Managing and controlling projects, including quality assurance processes, audit management, and document control;Working closely with project stakeholders to ensure that quality control systems are established, communicated, applied, and remain effective;Developing internal...


  • Hull, Kingston upon Hull, United Kingdom Pioneer Selection Ltd Full time

    Pioneer Selection Ltd is recruiting a Pre-Commissioning Specialist to cover client sites in the Yorkshire area. This is an excellent opportunity to work with a large Blue-Chip organisation that is consistently strengthening its position within the market.The successful candidate will provide pre-commissioning inspection services for pressure equipment and...


  • Hull, Kingston upon Hull, United Kingdom Bruin Full time

    Job TitleA Learning and Development Specialist is required to deliver essential training to staff in the aviation industry. The role involves creating comprehensive training courses and providing guidance to learners.Key Responsibilities:Deliver Human Factors, Safety Management Systems, Root Cause Analysis, and Fleet Planning training courses.Provide support...


  • Hull, Kingston upon Hull, United Kingdom Sanctuary Personnel Ltd Full time

    Are you passionate about providing exceptional support to individuals with mental health challenges and learning disabilities?About the Role:We are seeking a highly skilled Specialist Social Worker to join our High Needs Team in Kingston upon Hull. As a key member of our team, you will be responsible for delivering high-quality services to individuals with...


  • Hull, Kingston upon Hull, United Kingdom Travelex Full time

    Role OverviewAt Travelex, we're looking for a skilled Travel Money Specialist to join our team. As a key member of our retail environment, you'll be responsible for providing exceptional service to customers, helping them navigate our Foreign Exchange options, and delivering on our promise to fulfill their travel money needs.Key ResponsibilitiesNurture...


  • Hull, Kingston upon Hull, United Kingdom Pratap Partnership Full time

    Job Title: Financial Reporting SpecialistWe are seeking a highly skilled Financial Reporting Specialist to join our finance team at Pratap Partnership. As a key member of our team, you will be responsible for developing and implementing financial reporting processes, preparing reports, and ensuring compliance with regulatory requirements.About the Role:This...


  • Hull, Kingston upon Hull, United Kingdom Sacco Mann Full time

    The award-winning firm Sacco Mann is seeking a highly skilled Cyber Security and Data Protection Specialist to join their expanding team in Hull. This innovative firm has experienced significant growth and success, offering a unique opportunity for a dedicated solicitor.The UK's data protection and cyber security landscape continues to evolve, requiring a...