ADVANCED REGULATORY jobs in CAMBRIDGE, United Kingdom

Title: Director, Regulatory Affairs, Rare Disease Company: Ipsen Bioscience, Inc. Job Description: Director..., Regulatory Affairs, Rare Disease Summary / purpose of the position To be accountable for the strategy, tactics...

Job Purpose The Senior Manager, Medical & Regulatory Writing will be an integral part of MoonLake’s Clinical... Development team. You will lead a team responsible for developing the content for submissions to regulatory agencies...

Job Purpose As a Senior Manager, Regulatory Affairs CMC, you are an integral part of MoonLake’s Clinical Development... team responsible for the development, execution and tracking of regulatory CMC and medical device activities...

excellent relationships with regulatory authorities FDA. Minimum Advanced degree (or equivalent) in scientific discipline...Title: Director, Global Regulatory Affairs, Oncology Company: Ipsen Bioscience, Inc. Job Description: Director...

different stages of development through input and delivery of safety documents and regulatory reports. Your duties... for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines. Lead...

which life-threatening diseases are treated using advanced therapy medicinal products. Job Summary: The Senior QA Officer..., will be responsible for overseeing and ensuring compliance with relevant regulatory requirements and quality standards throughout the...

which life-threatening diseases are treated using advanced therapy medicinal products. Job Summary: The Senior QA Officer..., will be responsible for overseeing and ensuring compliance with relevant regulatory requirements and quality standards throughout the...

-functional system / process improvement initiatives. Supports internal audits and/or regulatory agency inspections, including..., and processes, and any regulatory or other requirements. REQUIREMENTS: We are all different, yet we all use our unique...

with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the most rigorous standards of quality, timely... the CPM in site selection, verify timely collection of essential study documents, such as regulatory and ethics committee...

with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the most rigorous standards of quality, timely... the CPM in site selection, verify timely collection of essential study documents, such as regulatory and ethics committee...

deviations) Work closely with CRA’s and research scientists. Interface with Program Management, Clinical Affairs, Regulatory... clinical performance, effectiveness, or safety of Software as a Medical Device (SaMD). You have a Bachelor’s or advanced...

compliance with accounting principles, standards, and regulatory requirements Coordinate the annual audit process and liaise... Proficiency in financial software and ERP systems; experience with Sage 200 Advanced Excel and modelling skills Knowledge...

consultancy businesses. We've supported the UK through times of war and peace, prosperity and recession, political and regulatory... under pressure and meet deadlines. Skills we'd love to see/Amazing Extras: Highly advanced with Microsoft Excel would be highly...

/BS or advanced degree in life sciences or related field with relevant experience in the biopharma industry, regulatory... includes understanding of global PV regulatory requirements related to the collection, processing and submission of ICSRs...

. Expectations for the above activities includes understanding of global PV regulatory requirements related to the collection... assigned function and team. Education and Experience: At a minimum, the ideal candidate will possess: BA/BS or advanced...

quality) or in response to Regulatory Authority requests. Lead the collection of material for periodic reports e.g. DSUR... close collaboration with the safety vendor to ensure appropriate case processing. Contribute to regulatory authority submissions...

scientific publications, book chapters, grant applications and regulatory documents Being self-motivated... reviews or meta-analyses Advanced skills in Excel and knowledge of VBA Familiarity with the R programming language...