Cynthia Athlan Email & Phone Number

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 managing the hands on daily business (post-approval changes but not only), and helping to shape the future Santhera through process improvments.

Allschwil, Ch

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 activities

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 including project schedules, costs, whilst ensuring highest quality.

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, responses to Health Authorities questions.Liaising with local affiliates, line functions and external companies for CMC regulatory issues: change control, compliance, renewals.Responsible for on average 15 number of projects (5 of them up to filling).Member of TRD pediatric working group.Job rotation in Regional Regulatory Affairs Project team member, responsible for a global change of sourcing covering French speaking countries in Africa, regulatory activities linked to these changes, regulatory strategy and ensuring implementation.Country management: single point of contact for all requests/issues for African countries.

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 well as answers to questions from Heath Authorities.Planning of a GMP pilot plant.Editing and supervision of SOP‘s,Technical assistance to the production department.

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, supervision of the production (short term replacements).

Pharmacist, Pharmacy

Master, Industrial Pharmacy, Option Production - Formulation