Aida Basic Email & Phone Number

Vienna, Austria

Wien, Österreich

Wien, Österreich

Leading a regulatory team in Switzerland and AustriaLocal Scientific Information Manager responsible for review and approval of promotional materials including complaint managementMake sure that high quality submissions (new applications and life cycle management) are performed in a timely manner and according to business requirementsManagement of health.

Austria

Managing maintenance and innovation activities for the CHC portfolio in AustriaLocal RA Business partnerReg. strategy for new OTC products (medicinal products, food supplements, medical devices, cosmetics) incl. claims, umbrella and switch strategy Promo materials regulatory review

Vienna

European Regulatory Affairs Manager for Pain Care CategoryDefining regulatory strategy (new products, geo-expansions, in-licensing) in the EUUmbrella brandingRx to OTC switchesManagement and submission of community procedures (MRP, DCP, RUP) for new submissions and maintenance activities

BI Regional Center Vienna

Consumer Health Care (OTC), CEE

Linz - Zürich- India

• Coordination of activities to support transfer of chemical production (APIs) from the Austrian manufacturing site to receiving sites in India within the strategic Operations Network Optimisation
• Representing the local transfer team at the global core team meetings
• Alignment meetings with the project teams at the receiving sites in India
• Project Management including implementation follow-up, timeline adherence, resource planning for the local transfer team, organisation of on-site support travels, monthly status reports for the core team and site.
• Participation in regulatory affairs work stream to prepare for the change in the API manufacturing site

• Responsible for CMC management for life cycle products manufactured at the site (including dossier upgrades, variations, renewals) and coordination of QC- and production activities to generate the necessary data
• Annual planning of upgrade activities and execution. Reporting of results to site management.
• Evaluation of change requests for finished products and APIs manufactured at the site regarding their regulatory relevance
• One point of contact at the site for regulatory affairs
• Contact with authorities regarding APIs (CEP, ASMF and DMF-submissions)
• Leading a team of approximately 4 colleagues

• Preparation of CMC documentation for products in development and clinical trial medication (IMPD)
• Coordination of QC- and manufacturing activities related to preparation of quality documentation (development and validation of analytical procedures, development of specifications, process validation, stability.
• Participation in cross functional teams and alignment meetings (regulatory, marketing, clinical research) with responsibility for CMC
• Upgrading dossiers and supporting marketing expansion activities
• In licensing support: review of CMC information as part of technical due diligence

Certificate Megra, Regulatory Affairs

Start-up 2014, certification 2016 A training course for beginners and update for professionals in RA

M.Sc. Pharm., Pharmacy