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Stirling Q&R

Stirling Q&R is a boutique recruitment firm specialising in connecting elite talent with transformative opportunities within the pharmaceutical, biotechnology, and medical device sectors, across the US and Europe for permanent and contract hires.

Related companies:

🏢 Luminary Group
🏢 Apellis
🏢 Precision Medicine Group

Jobs at this company:

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🔥 Regulatory Consultant (Biotech)
Posted 2024-11-07

📍 United Kingdom

🔍 Biotech

  • Bachelor's degree in Life Sciences, Regulatory Affairs, or a related field; advanced degree preferred.
  • 5+ years of experience in regulatory affairs within the biotech industry.
  • Demonstrated success in preparing and submitting regulatory applications.
  • In-depth knowledge of FDA and EMA regulations, guidance documents, and submission processes.
  • Strong analytical and problem-solving skills.
  • Excellent written and verbal communication abilities.
  • Ability to work independently and manage multiple projects simultaneously.
  • Proficient in regulatory submission tools and document management systems.
  • Regulatory Affairs Certification (RAC) or similar credential is desirable.
  • Experience with biologics, gene therapies, or combination products is preferred.

  • Advise clients on regulatory strategies to achieve compliance with FDA and EMA regulations for biotech products.
  • Review and prepare regulatory submissions, including INDs, BLAs, and CTAs.
  • Conduct gap analyses to identify areas for improvement in regulatory documentation.
  • Assist in the development and execution of responses to regulatory inquiries and actions.
  • Stay updated on changes in regulations and industry trends, providing recommendations to clients.
  • Prepare and conduct training sessions for client teams on regulatory requirements and best practices.
  • Build and maintain strong relationships with clients, fostering trust and collaboration.

Data AnalysisData analysisCommunication SkillsAnalytical SkillsCollaboration

Posted 2024-11-07
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🔥 Regulatory Writer
Posted 2024-11-07

📍 United Kingdom

🔍 Pharmaceutical or biotech

  • Bachelor's degree in a relevant scientific field; advanced degree preferred.
  • 3+ years of experience in regulatory writing within the pharmaceutical or biotech industry.
  • Proven expertise in preparing regulatory documents for submission to health authorities.
  • Exceptional writing and editing skills with a strong attention to detail.
  • Ability to distill complex scientific data into clear and concise language.
  • Strong organizational and time management skills to handle multiple projects simultaneously.
  • Proficient in Microsoft Office Suite and document management systems.
  • Desirable: Familiarity with eCTD submission formats, and certification in regulatory writing or related field.

  • Write, edit, and review regulatory documents, including INDs, BLAs, CTDs, and clinical study reports.
  • Collaborate with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance, to gather necessary information for document preparation.
  • Ensure all documents are compliant with relevant regulatory guidelines and company standards.
  • Conduct literature searches and summarize findings to support regulatory submissions.
  • Monitor project timelines and deliverables, ensuring timely submission of documents.
  • Maintain a thorough understanding of regulatory requirements and updates related to document preparation.
  • Participate in meetings with regulatory agencies as needed to provide clarification on submitted documents.

Project ManagementData AnalysisProject CoordinationData analysisCommunication SkillsAnalytical SkillsCollaborationMicrosoft ExcelMicrosoft Office Suite

Posted 2024-11-07
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🔥 GCP Auditor
Posted 2024-10-26

📍 United Kingdom

🔍 Clinical Research

  • Bachelor's degree in life sciences, nursing, or a relevant field; advanced degree preferred.
  • 5+ years of experience in clinical research, quality assurance, or auditing, with a focus on Good Clinical Practice.
  • Proven experience conducting GCP audits in clinical trials.
  • Strong analytical skills with attention to detail.
  • Excellent written and verbal communication abilities.
  • Ability to work independently and effectively manage multiple audits simultaneously.
  • Knowledge of relevant regulatory requirements and guidelines (FDA, EMA, ICH).
  • Certification in Clinical Research or Quality Assurance (e.g., ACRP, ASQ) is desirable.
  • Familiarity with electronic data capture (EDC) systems is desirable.

  • Conduct comprehensive audits of clinical sites, clinical trials, and study systems to assess compliance with GCP, applicable regulations, and internal SOPs.
  • Develop audit plans, execute audits, and prepare detailed audit reports summarizing findings, conclusions, and recommendations.
  • Collaborate with clinical and regulatory teams to address audit findings and develop corrective action plans.
  • Monitor the implementation of corrective actions and ensure timely resolution of identified issues.
  • Provide training and guidance to staff on GCP compliance and quality assurance practices.
  • Stay updated on changes to GCP regulations and trends in the clinical research industry.
  • Assist in regulatory inspections and support responses to regulatory queries related to audit findings.

Data AnalysisGCPQAData analysisCommunication SkillsAnalytical SkillsCollaborationAttention to detailWritten communication

Posted 2024-10-26
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🔥 Quality Assurance Director
Posted 2024-10-25

📍 United Kingdom

🧭 Full-Time

🔍 Medical devices

  • Bachelor's degree in Life Sciences, Engineering, or a related field; advanced degree preferred.
  • A minimum of 8 years of experience in quality assurance within the medical device or pharmaceutical industry.
  • Extensive knowledge of ISO 13485, FDA regulations, and EU MDR requirements.
  • Proven leadership experience with a track record of successfully managing quality systems.
  • Strong analytical skills and ability to drive data-informed decisions.
  • Exceptional communication and interpersonal skills, with the ability to influence and work effectively with diverse teams.
  • Experience in developing and leading training programs related to quality assurance.
  • Ability to travel as required for audits and inspections, both domestically and internationally.

  • Develop and implement the quality assurance strategy, policies, and procedures in alignment with company goals.
  • Lead the Quality Assurance team in monitoring adherence to policies and regulatory compliance;
  • Ensure that quality management systems meet industry standards.
  • Oversee audits and inspections, ensuring readiness for both internal and external reviews.
  • Collaborate with cross-functional teams including R&D, manufacturing, and regulatory affairs to ensure quality is integrated throughout the product lifecycle.
  • Provide training and support to staff on quality systems and regulatory requirements.
  • Manage and investigate product complaints and adverse events, implementing corrective actions as necessary.
  • Evaluate quality performance metrics and drive continuous improvement initiatives.
  • Act as a key representative in front of regulatory agencies and maintain relationships with external partners.
  • Stay updated on industry trends and regulatory changes; ensure the company adapts accordingly.

LeadershipData AnalysisPeople ManagementQACross-functional Team LeadershipData analysisGoCommunication SkillsAnalytical SkillsCollaborationProblem SolvingMentoringNegotiationAttention to detailOrganizational skillsPresentation skillsTime ManagementWritten communicationDocumentationComplianceCoaching

Posted 2024-10-25
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