Michael Schaub

Establishment and maintenance of Asphalion Munich Office International drug development and regulatory affairs projects during development, registration, life-cycle and pharmacovigilance; budgeting and resources planning, project management Commercial, marketing and BD activities, including account management, customer acquisition, RFP bidding, contract negotiations, conduct of regulatory affairs seminars, management of partners and suppliers, assistance for preparation of marketing and commercial plans

Formulation of company and services strategy, internal and external strategic business analysis, definition of competitive advantage strategy and value proposition, set-up of medium-term corporate and services objectives, preparation and monitoring of short-term action plans for achievement of objectives, implementation and maintenance of strategy execution system, establishment and follow-up of commercial plans for services and teams, revenue forecasting and profitability analysis for each business line

Market analysis, preparation of marketing and commercial plans, planning and execution of marketing and sales campaigns, account management and customer acquisition, implementation of new services Regulatory affairs procedures in the context of EU and US legislation, regulatory strategy during drug development, regulatory advice for biotech and start-up companies, negotiations with regulatory authorities, electronic regulatory information management, conduct of regulatory affairs seminars and workshops

Scientific writing (as in Officer role), management of EU registration, paediatric investigation plan, scientific advice and orphan drug designations procedures, review and gap-analysis of CTD documentation, coordination of build-up of CTD registration dossiers, eSubmission publishing and life-cycle management according to eCTD and NeeS format for EMA/EU-NCAs and FDA, conduct of software training and first-level support for Extedo eCTDmanager and PcVmanager

Scientific writing for CTD Modules 2.5/2.7/5/2.4/2.6/4, Module 1.6 environmental risk assessment, investigator’s brochure, investigational medicinal product dossier, preparation of scientific advice briefing packages, writing of journal articles

Tour-guide for MTB vacation trips in Austria, Switzerland, Italy and France; mostly 1-week alp-cross tours from Austria till Northern Italy

Immunology, Protein Structure Determination using X-ray Crystallography, Pharmacology, Microbiology