Regulatory Affairs Specialist

3 days ago

Slough, United Kingdom Stirling Q&R Ltd Full time

**Job Title**: Regulatory Lifecycle Specialist **Department**: RAQA **Reports To**: RAQA Manager **Position Summary**: Working under the guidance of the Quality Assurance and Regulatory Manager, the Regulatory Lifecycle Specialist will execute regulatory assurance activities, ensuring product life cycle compliance with identified regulations and standards in the UK and Ireland. **This is a fixed-term-contract for 12-18 months.** **Key Responsibilities**: - Compile technical documentation and STEDs. - Write and review device compliant documentation for EU submissions (MDR-IVDR). - Review submission documentation for compliance with regulations, standards, and guidance. - Manage license and registration submissions and renewals. - Monitor submission deadlines and progress, reporting as required. - Respond to queries from MOH bodies. - Review significant product and process changes. - Maintain and collate PMS / PSUR data. - Provide Sheffield support, including data establishment and collaboration on QA documents. - Oversee batch history sign-off, filing, and archiving. **Competencies**: - Proficient in processing large amounts of data with precision. - Applies feedback for performance improvement, demonstrating accuracy and commitment to excellence. - Achieves established goals and productivity standards. - Adapts to new technologies, troubleshoots problems, and utilizes technology for increased productivity. - Edits work for clarity and effectiveness. - Accepts criticism and feedback, adapts to changes, and manages competing demands. - Collects, researches, and synthesizes complex information. - Maintains punctuality and attendance. **Qualifications**: - **Education/Experience**: Fifth-year college or university program certificate; or two to four years of related experience; or equivalent combination. - **Language Ability**: Proficient in English, both spoken and written. - **Mathematical Ability**: Basic mathematical operations and interpretation of data. - **Reasoning Ability**: Solves practical problems and deals with a variety of variables. - **Computer Skills**: Proficient in Excel, Word, SharePoint, PowerPoint. - **Certificates and Licenses**: Qualification in Word and Excel desirable. **Supervisory Responsibilities**: N/A **Work Environment**: Office-based **Physical Demands**: Some manual lifting (

  • Regulatory Affairs Manager

    5 days ago

    Slough, Berkshire, United Kingdom Atrio Search Full time

    My client is looking for a Regulatory Affairs Manager (Independent Consultant) to strengthen its European regulatory affairs team and support the registration of plant protection products in the United Kingdom. Mission 1 – Manage UK Ecotoxicology Registrations Prepare, submit, and maintain registration dossiers for plant protection products under the UK...

  • Senior Regulatory Affairs Manager

    4 days ago

    Slough, Berkshire, United Kingdom WEP Clinical Full time

    Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring ideas that make a real difference. Be part of a...

  • Associate Director Regulatory Affairs

    3 weeks ago

    Slough, Berkshire, United Kingdom Cpl Life Sciences Full time

    Title: Global Associate Director, Regulatory Affairs Job Type: Full-time permanent position Location: West London, UK – 3x a week in the office Salary: £90,000 - £100,000 + Car Allowance + Bonus Working for one of the industry's leading pharmaceutical companies, this is a fantastic opportunity to provide expert regulatory knowledge from pre-clinical...

  • Regulatory Affairs Associate

    2 weeks ago

    Slough, United Kingdom Reckitt Full time

    Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a...

  • Regulatory Affairs Officer

    6 days ago

    Slough, Berkshire, United Kingdom Pay.UK Full time

    Regulatory Affairs Officer, London, Permanent Join Pay.UK's Regulatory Affairs team and play a pivotal role - you'll help assess and manage regulatory expectations across economic, macroprudential and supervisory frameworks, ensuring our business stays compliant and innovative. You'll combine sharp analytical skills with a deep understanding of legal and...

  • Global Regulatory CMC Lead

    6 days ago

    Slough, Slough, United Kingdom UCB Full time €60,000 - €120,000 per year

    Make your mark for patientsWe are looking for aGlobal Regulatory CMC Leadto join us in ourRegulatory Affairsteam, based in either our Brussels (Belgium) or Slough (UK) offices.About The RoleThe Global Regulatory Affairs CMC Lead is responsible for defining strategy, planning and preparation of regional specific CMC submission documentation on developed...

  • Global Regulatory CMC Lead

    7 days ago

    Slough, United Kingdom UCB S.A. Full time

    Make your mark for patients We are looking for a Global Regulatory CMC Lead to join us in our Regulatory Affairs team, based in either our Brussels (Belgium) or Slough (UK) offices. About the role The Global Regulatory Affairs CMC Lead is responsible for defining strategy, planning and preparation of regional specific CMC submission documentation on...

  • QA Specialist

    1 day ago

    Slough, United Kingdom Quanta part of QCS Staffing Full time

    QA Specialist – Bio-pharmaceutical - Slough We are looking for an experienced QA Specialist for a fantastic 12 month contract based in Slough. Working with our client, a global bio-pharmaceutical organisation committed to improving the lives of people afflicted with neurological and immunological disease, you will be the HPQE in GCSO quality and compliance...

  • Manager, Medical Affairs

    4 days ago

    Slough, Berkshire, United Kingdom Insulet Corporation Full time

    Position Overview Reporting to the Snr Medical Affairs Manager – EU Distributor Markets, the Medical Affairs Manager will be responsible for developing and executing the Medical Affairs strategy in a selection of EU distributor markets where Insulet doesn't have a direct presence in Europe. In conjunction with the Snr Medical Affairs Manager, the Medical...

  • Head of Corporate

    5 days ago

    Slough, United Kingdom Reckitt Full time

    Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a...