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Cynthia Athlan is listed as Regulatory CMC expert at Santhera Pharmaceuticals, based in Basel Metropolitan Area, Switzerland, Switzerland. AeroLeads shows a work email signal at santhera.com and a matched LinkedIn profile for Cynthia Athlan.
Cynthia Athlan previously worked as Senior Manager Technical Regulatory Affairs (CMC) at Santhera Pharmaceuticals and Senior CMC Manager (4 months contract) at Polyphor Ltd. Cynthia Athlan holds Pharmacist, Pharmacy from Université D'Aix-Marseille.
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very good technical background, with initial career in pharmaceutical development (strongest focus on solid oral dosage forms), expert in process validation, good knowledge in Quality management, regulatory expertise in CMC (chemistry, manufacturing and controls)Specialties: CMC matters: high level of expertise with EU and US regulations, medium level with Canadian, Australian and Japanese regulationsFull scope of Regulatory matters for Switzerland (CMC and non CMC)
Listed skills include Regulatory Affairs, Regulatory Submissions, Pharmaceutical Industry, Validation, and 45 others.
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Pratteln, Basel-Country, CH
joining Santhera at very short notice, I managed to prepare the Module 3 for US and EU submissions in record time, dealed with the lists of questions in parallel and contributed substantially to the successful approval (EMA/FDA/MHRA).A nice challenge to be added to the list of successes and achievements!Now supporting the geographical expansion whilst.
Canonsburg, Pennsylvania, US
All activities related to initial submissions and life life cycle management, for a portfolio including established products, biosimilars, vaccines and generics.Focus on Swiss market (Swissmedic)Fixed term employment
In addition to previous role, lead a team of up to 4 RA managers, overseeing a portfolio of around 80 products (small molecules) either owned by Lonza or customers.The portefolio includes APIs, intermediates of APIs, linkers and toxin-linkers for ADCs.Registration activities cover all regions.
Performing all activities related to the preparation (inl. authoring, review, update, answers to questions, regulatory guidance...) of the Drug Substance part of Regulatory files (for all phases: early to late development, initial filing and post-approval changes). Portfolio includes biologics and small molecules.Participating to Regulatory Intelligence.
Tel-Aviv, IL
Performing all regulatory activities related to national licences: initial submissions, renewals, variations, evaluation of change requests, coordination of activities with Supply Change Department as well Quality Assurance.The range of products (portfolio of around 60 products) includes mainly generics, but also biosimilars and “branded products”.
Bern, CH
Assessing Quality (CMC) part of submissions, member of cross-functionnal teams for the evaluation of NCE,s, member of the implementation team for electronic submissions, reviewer/co-author of national and international guidelines
Basel, CH
Managing the development of new dosage forms, leading the technical team for assigned projects, contributing to the selection of development and/or manufacturing partners for outsourced activities, providing technical expertise to contract partner and technical/general input as a member of cross-functional project teams, monitoring project activities.
Basel, Baselstadt, CH
Regulatory Manager: coordinating, authoring and preparing CMC documentation for clinical trial applications and marketing authorisations for worldwide submissions of new developed drug products, providing regulatory expertise to project teams on CMC related points.Preparing, compiling and submitting documentation for CMC variations and site transfers.
Head of Pharmaceutical DevelopmentManaging a team of 10 people (incl. 3 pharmacists).Development of generics and new chemical entities, incl. scaling up and validation,Manufacturing of clinical trial material (CTM), and implementation of a Quality Assurance System for CTM.Editing and reviewing technical part of regulatory submissions (parts IIA and IIB) as.
Basel, BS, CH
Development of pharmaceutical products (generics: solids and liquids dosage forms), up to the production scale, redaction of production documentation, validation of methods of manufacture,Manufacturing of clinical trial material CTM.Editing SOP‘s, participation to the GMP audits.Support to production for technical issues.
St. Gallen, Switzerland, CH
Development PharmacistDevelopment of solid forms (OTC products: tablets, coated tablets, granules, effervescents, capsules) from the development stage to the first production batches, follow up of stability testsTraining of technicians (technical / IT) of R&D and Quality Control departmentsEditing SOP‘s and Site Master File.Editing manufacturing methods.
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Cynthia Athlan works for Santhera Pharmaceuticals.
Cynthia Athlan is listed as Regulatory CMC expert at Santhera Pharmaceuticals.
AeroLeads has found 1 work email signal at @santhera.com for Cynthia Athlan at Santhera Pharmaceuticals.
Cynthia Athlan is based in Basel Metropolitan Area, Switzerland, Switzerland while working with Santhera Pharmaceuticals.
Cynthia Athlan has worked for Santhera Pharmaceuticals, Polyphor Ltd, Home, Sweet Home ;-), Mylan, and Lonza.
You can use AeroLeads to view verified contact signals for Cynthia Athlan at Santhera Pharmaceuticals, including work email, phone, and LinkedIn data when available.
Cynthia Athlan holds Pharmacist, Pharmacy from Université D'Aix-Marseille.
Cynthia Athlan is listed with skills including Regulatory Affairs, Regulatory Submissions, Pharmaceutical Industry, Validation, Gmp, Pharmaceutics, Cmc Regulatory Affairs, and Regulatory Requirements.
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