Dorte Friis Christensen Email and Phone Number
Dorte Friis Christensen work email
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Dorte Friis Christensen personal email
Expertise in CMC documentation generated from more than 20 years of CMC experience in the pharmaceutical industry, through development and product life cycle activities.I am excellent in navigating cross functional and cooperate with experts in manufacturing, QC and development as well as external partners of different nationalities.I often act as a scientific mediator between regulatory and manufacturing functions to ensure that the right level of documentation is delivered in a structured form.• Biologic and small molecules in various dosage forms• CMC documentation for Global regulatory MAA/NDA/BLA submissions and life cycle• Project leader for scientific document teams• Thrives in dynamic and changing environments• Strong analytic mindset, work with details as well as the bigger picture• Strong communication skills• People managementAs a person I am positive, flexible, pragmatic, accountable, cooperative and realistic.
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Director, Cmc Tablets & Next Generation, Global Regulatory AffairsAlk Jul 2022 - PresentDenmark -
Manager, Cmc Tablets & Next Generation, Global Regulatory AffairsAlk Abelló Oct 2014 - Jun 2022Hørsholm, Denmark
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Director Global Regulatory Affairs CmcTakeda Pharmaceuticals (Former Nycomed) May 2007 - Sep 2014Roskilde, Denmark• Part of strategy discussions for regulatory CMC during two mergers; Nycomed - Altana and Takeda – Nycomed• Project leader for CMC submissions teams for new MAA (biologics and small molecules)• Providing regulatory CMC support to the lifecycle activities of a high number of various products, with different dosage forms and submission processes globally• Writing of Expert Reports/ Quality Overall Summaries• EDMS template author for module 2.3 and 3 document templates• Manager for 1 - 3 persons in direct reporting -
Manager, Cmc Documentation Competance CenterNycomed Jan 2003 - Apr 2007Roskilde, Denmark• Stay updated with technical guidelines and support technical scientists• Establishment of strategy for technical documentation for Module 3• Interact with regulatory affairs• Approval of Drug Product specifications• Training of scientist in document requirements for content and layout to fulfil eCTD requirements• Write Expert Reports / Quality Overall Summaries -
Head Of Pharmaceutical And Analytical DevelopmentNycomed Pharma Nov 1994 - Dec 2002• Manager for 8 -18 persons in direct reporting• Strategy for the department and interactions with QC and manufacturing sites• Development of staff, responsible for employment and dismissals• GMP, Laboratory equipment and software’s• Planning of laboratory logistics and people allocation to various project• Scientific support• Approval of documents; stability protocols and reports, analytical methods, method validation reports, product specifications, formulation documents, transfer protocols
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Analytical Research ScientistNycomed Pharma / Benzon Drug Delivery Jun 1993 - Oct 1994Hvidovre, Denmark
Dorte Friis Christensen Skills
Dorte Friis Christensen Education Details
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Chemical Engineering -
MedicademyDiploma In Regulatory Affairs -
Hovedstadens LaborantskoleLaboratory Technician
Frequently Asked Questions about Dorte Friis Christensen
What company does Dorte Friis Christensen work for?
Dorte Friis Christensen works for Alk
What is Dorte Friis Christensen's role at the current company?
Dorte Friis Christensen's current role is CMC senior expert with extensive regulatory and management experience.
What is Dorte Friis Christensen's email address?
Dorte Friis Christensen's email address is do****@****eda.com
What schools did Dorte Friis Christensen attend?
Dorte Friis Christensen attended Danmarks Tekniske Universitet / Dtu, Medicademy, Hovedstadens Laborantskole.
What skills is Dorte Friis Christensen known for?
Dorte Friis Christensen has skills like Regulatory Affairs, Cmc, Pharmaceutical Industry, Regulatory Submissions, Analytical Chemistry, Gmp, Pharmaceutics, Regulatory Requirements, Ectd, Cmc Regulatory Affairs, Gxp, Cmc Development.
Who are Dorte Friis Christensen's colleagues?
Dorte Friis Christensen's colleagues are Shandi Green, Majse Kruse Gormsen, Laurène Huguier, Ghassan Qutob, Laure Nussaume, Anabel Hidalgo Moreno, Lori Kroiss.
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