Roman Goetz

• Project management / project coordination of nonclinical development programs; interaction with and management of CROs • Scientific and regulatory writing, including IND, IMPD, IB, biological safety evaluations for medical devices, briefing documents for interaction with regulatory bodies; all with focus on nonclinical content • Administrative and procedural preparation of interaction with regulatory bodies (scientific advice meetings) • Compilation of research and study reports; quality control of data

Consultancy company specialized in non-clinical, toxicology and regulatory consulting to pharmaceutical companies and biotech • Project management (as a service) for customers’ early development projects (pre-clinical stage) • Planning, review and project coordination of nonclinical study programs • Communication and coordination with CROs • Writing and compilation of regulatory documents • Preparation of meetings with regulatory agencies • Writing of research study reports • Quality control of data

- Project management (as a service) for customers’ early development projects (pre-clinical stage) - Communication and coordination with contract research organizations - Planning, review and project coordination of toxicology study programs

Biopharmaceutical development company in women’s healthcare sector with a portfolio of novel compounds for treatment of preterm labor and primary dysmenorrhea • Leading a virtual team of qualified experts to successfully complete the first clinical development stage of the company’s lead compound • General tasks and duties of Managing Director position, including financing, legal, personnel

• Control of timelines, budgets and deliverables in pre-clinical and clinical development • Selection, contracting, communication and coordination with CROs • Project management and hands-on coordination of all CMC and nonclinical development work • Writing and compilation of regulatory documents at preclinical and clinical development stage

• Balancing project resources in a multi-project environment • Control of project timelines, budgets and deliverables, integrated into strategic portfolio management • Successful re-launch of a previously abandoned development project • Successful implementation of pandemic influenza threat management plan

• Management of tech transfer projects, including coordination of production, production planning and raw material supplies in start-up phase • Contribution to major portions of regulatory registration dossiers (CMC section) for approval by US and European health authorities

- Responsible for personnel and budget of process validation department - Setting and controlling of performance objectives of staff - Implementation of standards and operating procedures - Team successfully completed projects that were resulting in regulatory approval of the top seller of the business unit

- Coordination of validation projects - Supervision of validation staff members - Preparation of validation documentation - Successfully consolidated validation group in an organizational transition period

- Patent attorneys’ association of two attorneys, focusing in the fields of chemistry, chemical engineering, metallurgy and mechanical engineering. - In a trainee position: - Collaboration in preparation of patent and trademark applications, formal correspondence and written submissions to the US, European, and national patent offices - Formal professional training in European patent law (1 year)

• Studies of chemistry, specialization in chemical engineering and analytical chemistry • Master Thesis at University of Amsterdam • PhD Thesis at Vienna University of Technology