Leading the development and execution of strategies to drive business growth and expand Asphalion's client baseResponsible for defining and implementing global commercial strategies, analysing key performance indicators, and ensuring customer satisfactionIdentification of new business opportunities, building and maintaining relationships with key stakeholders, and overseeing the marketing and branding efforts to position Asphalion as a leader in the industryRepresenting the company externally and assess potential partnerships, while maintaining an excellent understanding of target audiences and competitor analysisClose collaboration with the commercial team to manage key customers, maintain positive team culture, and communicate customer requirements throughout the businessResponsible for maintaining quality standards in commercial activities and providing regular feedback to the Steering Committee on team performance

Establishment and maintenance of Asphalion Munich OfficePlanning and set-up of international drug development and regulatory affairs projects for drugs and medical devices during product development, registration, life-cycle and pharmacovigilance; project management functions including planning and coordination of internal and external resources; control of project budgetsCommercial, marketing and business development activities, including account management, new customer acquisition, RFP bidding, contract negotiations, execution of marketing and sales campaigns, conduct of regulatory affairs seminars, event planning and organization, management of partners and suppliers, assistance for preparation of yearly 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 opportunity assessment, preparation and maintenance of marketing and business development plans, planning and execution of marketing and sales campaigns, account management and new customer acquisition, implementation of new servicesPlanning and management of regulatory affairs procedures in the context of European and North-American legislation, regulatory strategy during drug development, regulatory advice for biotech and start-up companies, negotiations with regulatory authorities, electronic regulatory information management, project resources planning, conduct of regulatory affairs seminars and workshops

Scientific writing (as below 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

Participation in the project: “The Proteomic Interactome of the Progesterone Receptor in Human Breast Cancer Cells”

Biochemical Analysis of RNA-Protein Interaction; Use of Bioinformatics Tools and Reporter Gene Constructs for Investigation of Eukaryotic Translation MechanismsBiochemical Analysis and in vitro Splicing Assays Utilizing HIV-1 tat minigene Substrates to characterize Splicing Regulatory Functions

Tour-guide for MTB vacation trips in Austria, Switzerland, Italy and France