Dr. Michael Nowak

Industrial affairs (IA) product & portfolio management (PPM) and Primary IA Business Partner for global CHC Category Team Digestive Health. Align product industrial strategy and LCM road map with global CHC category priorities. Trigger specific IA initiatives aiming at portfolio simplification & optimization, design-to-cost, design-to-value through metrics & portfolio analysis (with regard to gross margin and/or complexity). Support CHC innovation & launches.

Lifecycle management and product maintenance for international Consumer Health Care (CHC) core brands and interface management between pharmaceutical production (internal & external supply) and CHC business (e.g. Commercial Operations, M&S, Bus. Dev.)

Definition and implementation of corporate quality / GMP standards to meet regulatory & quality standards, ensure compliance and to prevent/mitigate quality risks for the global BI operations and development networks

Cross-site governance for GMP QA Management processes related to IMPs within Development Germany (e.g. Complaint- and Recall managment, Deviation/OOS-, CAPA &Change Control), incl. responsibility as “Pharm. Stufenplanbeauftragter" (Complaint officer for IMPs) according to AMG (German Medical Law) and Safety Officer for investigational medical devices (IMDs) according to §30 MPG (German Medical Devices Law). 6 direct and 8 indirect reports at German Development sites + 2 functional reports from Dev. USA.

Leading global strategic projects / initiatives and corresponding teams within corporate board Division Research, Development & Medicine (RDM), including strategy development and implementation, off-shoring as well as innovation and change management. Functional reporting to head of global R&D and/or head of coproate board division RDM.

Lead of interdisciplinary R&D Project Teams with up to 15 representatives from Research, Development, Operations and DRA from Start of Development until 1st MAA Submission. Representation of R&D in international project core teams and regular reporting to decision bodies owned by head of global R&D or head of corproate board division Research, Develoment & Medicine (RDM)

Analytical Development for respiratory drug products from start of Development until 1st MAA submission. Representation of Respiratory Durg Delivery (RDD) in R&D project teams. Supervision of internal & external scientific writers for analytical quality documentation. Indirect Lead of a document management team for preparation and management of controlled documents. Responsibility for 6 direct and 4 indirect reports.

Late stage analytical development /testing of conventional dosage forms (incl. preparation of analytical quality documentation for submission to relevant health authorities and follow-up) and analytical development for selected eraly stage respiratory drug products.

'Promotions-Studium' to achieve a doctoral degree in natural sciences (‘PhD’). Title of PhD-Thesis: “Stationary phases for anion exchange chromatography – new strategies for preparation and characterization”

Diplom-Studium to achieve Diploma (‘Graduate’) in Chemistry. Title of Diploma-Thesis focussing on Analytical Chemistry: "Preparation and application of highly cross-linked anion exchangers for trace analysis”