Dr. Conelious Pfumbidzai

PhD-qualified pharmaceutical and medical devices professional with prior experience in regulatory affairs. Looking for interesting opportunities.

• Regulatory Affairs Consultant for international life science industries. • Providing tailored strategic regulatory advice to international pharmaceutical and medical device companies. • Review Technical Dossier for medical products for international life science industries and advise on deficiencies. • CE Approval and Creation of Technical Dossier Class I/II/ III for Medical Devices • Clinical Evaluations • Technical Business Development and Product development

Providing tailored strategic regulatory advice to international pharmaceutical and medical device companies. Perform reviews and preparation of Technical Dossiers in accordance with the guidelines ISO 13485, MDD 93/42/EEC and European Medical Device Regulation (MDR), IVDD 98/79/EC and European In Vitro Diagnostic Device Regulation (IVDR). CE Approval and Creation of Technical Dossier Class I/II/ III for Medical Devices Technical Business Development and Product development

• Clinical Evaluations / Investigations for active medical devices

• Provision of tailored strategic regulatory advice to pharmaceutical and medical device companies. • Preparation and review documents for regulatory submissions. • Monitoring and assessment of developments in the EU and Swiss regulatory environments for drugs, biologics, medical devices. • Coordination of international consultant network for local regulatory intelligence projects. • Cross-functional support for other specialist areas within the company (medical communication, legal and public affairs).

• Addressing unmet needs in rare and neglected diseases for the benefit of suffering patients. • Updating and performing quality control of websites on rare diseases. • Drug market monitoring.

• Strategic market access planning and pricing in a range of pharmaceutical areas, including orphan, oncology, cardiovascular diseases. • Designed and managed the company interviewees database.

• Analysing drugs during in-process controls. • Controlling the quality of the finished products. • In sight into the development and improvement of methods used in drug analyses.

Noble metal nanoparticle synthesis and application, Peptide chemistry, Combinatorial chemistry

Multiple step organic synthesis, Liquid and Solid Phase peptide chemistry.