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CMC Submission Specialist within the pharmaceutical industry, experienced in the process of planning and authoring the Quality Dossier of a New Drug Application (NDA) within the areas of haemophilia and diabetes.Previous experience: Project Management Professional within the pharmaceutical industry with extensive experience in managing projects from pre-clinical phase to filing a NDA. Expert at constructing and communicating complex project plans and timelines. Strong scientific background within the field of Chemistry, Manufacture, and Control (CMC) from a protein/peptide based pharma company; highly experienced within the field of drug/device combination products. Strong written and verbal communication skills. Native Danish, fluent English, conversational Swedish, basic French and German.Specialties: CMC/Regulatory, NDA/BLA/MAA filing process (Quality dossier), Drug/device combination products, Primary packaging materials, Project planning, Product development, Insulin formulation, Timeline construction & visualisation, Training, Authoring of user guides
Docs In A Row Llc
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Consultant, Self EmployedDocs In A Row Llc 2018 - Present
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Cmc Submission SpecialistNovo Nordisk 2012 - 2017Bagsværd, DkContributed to the planning and execution of the different stages and elements of the Marketing Authorization Approval (MAA)/NDA process within the Quality (CMC) area. Planned and facilitated the pre-writing activities including regulatory risk assessment, story line definitions, training, and establishment of the Common Technical Document (CTD) document plan. Reviewed regulatory documents prepared by scientists in Module 2.3 and Module 3 in the CTD, ensured alignment and consistency in relation to language, readability, level of details, and adherence to story lines. Prepared selected documents.Secured that learnings and feedback from the health authorities was continuously captured and implemented in the Quality sections of NDAs of future projects. -
ConsultantGenentech 2010 - 2012South San Francisco, California, UsProvided support on a variety of levels in a newly formed device development department. Secured lab operations procedures at an appropriate quality level, aligning with global company Regulatory and Quality policies. Participated in a team developing a Generic Device Development Timeline, specifically establishing the graphic timeline, providing overview of the entire development process with sub-processes, durations, links to other activities, and company milestones. -
ConsultantRatio Inc 2010 - 2012Advisor to the company's founder and CEO concerning developing and testing a skin-mounted patch pump for subcutaneous (or intradermal) injection. Special focus on drug interactions with primary container, material suitability and selection, appropriate drug-device testing and the FDA's Regulatory Requirements.
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ConsultantBiomarin 2009 - 2010San Rafael, Ca, UsProgram Management in a drug/device combination product project in early clinical development, intended for treating PKU. Researched the current market of suitable injection devices, providing solid basis for choosing the optimal medical device for self administration of drug for the particular patient population. Provided input for interpretation of FDA Guidelines related to requirements for drug-primary container compatibility testing. -
Consulting Project ManagerDiadexus 2008 - 2009Project Manager for multiple projects, enabling the establishment of a medical diagnostic test application (PLAC test) at various laboratories. Managed cross-functional project teams, implemented a project management structure tailored to suit the company's specific needs. -
Project Manager In Cmc/RegulatoryNovo Nordisk Delivery Technologies 2006 - 2008Bagsværd, DkCMC/Regulatory Project Manager for pulmonary delivery of human insulin via a proprietary system incorporating a technologically advanced delivery device & a unique insulin dosage form (clinical phase 3).
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Cmc Project Manager, Drug/DeviceNovo Nordisk Delivery Technologies 2002 - 2006Bagsværd, DkPart of a team of specialized CMC Project Managers, each coordinating several projects from the 'discovery' phase through phase 3 clinical trials.CMC Project Manager responsible for a drug project and a combination drug/device project (the latter developing novel primary packaging materials/technologies for pharmaceutical proteins in liquid formulations, later transferred to a new medical device development project team).
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Formulation Scientist (Insulin & Insulin Analogues)Novo Nordisk Delivery Technologies 1995 - 2002Bagsværd, DkPart of a team of formulation scientists developing liquid insulin/insulin analogue drug products from pre-clinical to clinical phase 3 and filing of an NDA.
Signe Christensen Skills
Signe Christensen Education Details
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Copenhagen University College Of EngineeringChemistry -
Dtu - Technical University Of DenmarkChemical Engineering
Frequently Asked Questions about Signe Christensen
What company does Signe Christensen work for?
Signe Christensen works for Docs In A Row Llc
What is Signe Christensen's role at the current company?
Signe Christensen's current role is Consultant, self employed.
What is Signe Christensen's email address?
Signe Christensen's email address is ch****@****ene.com
What schools did Signe Christensen attend?
Signe Christensen attended Copenhagen University College Of Engineering, Dtu - Technical University Of Denmark.
What skills is Signe Christensen known for?
Signe Christensen has skills like Fda, Biotechnology, Clinical Development, Pharmaceutical Industry, Program Management, Cross Functional Team Leadership, Drug Development, Medical Devices, Research And Development, Product Development.
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