Regulatory & Quality Manager
Stablepharma are looking to appoint a Regulatory & Quality Manager that will be directly supporting the Chief Science and Development Officer (CSO)
Stablepharma Ltd. is a biotech company focused on the development of thermostable vaccines in preloaded syringes. Avoiding refrigeration and simplifying use will enable effective vaccine stockpiling and delivery anywhere in the world. Stablepharma is a UK-headquartered biotech with R&D Centre of Excellence in Madrid, Spain.
We are a dynamic, high-growth company and recently closed part 1 of our Series A round. Following very encouraging data on our COVID mRNA and Tetanus diphtheria (Td) programmes, and additional funds, we are now expanding our team significantly.
We have created a new and exciting position for a Regulatory & Quality Manager, based in Madrid (SPAIN ) that will be directly supporting the Chief Science and Development Officer (CSO) have following key duties and responsibilities:
• Work with the CSO to support the development of StablePharma vaccines from design, pre-clinical, clinical and market authorisation.
• Ensure that document traceability and necessary Quality Management System certifications are met.
• Provide regulatory and quality support to research and development activities carried out internally or by subcontractors.
• Engage with preclinical toxicology advisors and subcontractors.
• To engage with regulatory authorities and agencies.
• Contribute to building and putting together the Common Technical Document for submission for marketing approval of StablePharma reformulated vaccines.
• Bachelor in Life Sciences (BSc), preferably pharmacy.
• At least 5 years’ experience in quality and regulatory environments in pharma sector.
• Good understanding of the overall drug and vaccine development process.
• Fluent oral English and skilled Word writer.
• You will have the entrepreneurial spirit, ambition and enthusiasm required to drive growth for a high-potential start-up.
• You will be an excellent communicator and networker, a proactive problem solver, analytical with acute attention to detail.
• Eligibility and available to work 5 days a week in Madrid office.
Please send your CV with a cover letter to firstname.lastname@example.org