Smita B. Email & Phone Number

Bavaria, Germany

Munich, Bavaria, Germany

Greater Munich Metropolitan Area

At Kymanox Europe, my role is to support the pharmaceutical, biotech, and medical device industry globally by managing the design and development of medical device/combination products (drug/device and biologic/ device combination products in EU & US) through the entire product lifecycle. Backed by a strong background in regulatory affairs, Pre-clinical/Clinical trials provide innovative, resource-efficient solutions for developing/compiling compliant technical documentation and Design Dossiers to support device/combination product submissions for Notified Body opinion, IND, BLA, NDA for the expanding Biosimilar and combination product market. As a consultant and Project Manager my role is to provide strategic planning, drive risk management and QMS activities during development & post-launch, execute Design Control activities, develop Technical Documents/DHF (in compliance with regulatory standards: MDR, 21 CFR part 820 & part 4, ISO 13485, ISO 14971) for their submission to regulatory Bodies & provide regulatory guidance to help new entrants in the Biosimilar market to get their product to the Clinics/market.

Munich, Bavaria, Germany

Regulatory affairs Officer at a Munich based CRO. Working efficiently across programs and cross-functional teams to support and execute regulatory strategies / submissions for various drug / device and non-interventional post marketing studies in major European countries. (specialty areas: Cardiovascular; Oncology and Respiratory diseases: Study Start up, Phase I, Phase III, Post Market NIS/Observational studies). Interact with Regulatory Agencies on behalf of study sponsors before, during and after approvalProvide strategic regulatory guidance to project teams, upper management and study sponsors. backed with excellent understanding of EU, ICH regulations and guidelines.Ability to work independently and manage multiple tasks simultaneously under time constraints with excellent prioritisation skills. Strategic thinker, solution oriented, Team player with strong interpersonal abilities and excellent communication skills

Munich Area, Germany

Regulatory affairs expert working efficiently on industry sponsored /IITs across drug/ device studies. Working efficiently with cross-functional teams to support and execute regulatory submissions in major European countries. Responsibilties include, but not restricted to : Preparation of submission dossiers according to the requirements of the relevant authorities (EMA, National Authorities, Ethics committees) for all types of regulatory activities (e.g. Initial, amendments, DSUR, renewals)Re-work and formatting of documents for submission readiness. Interacting with Regulatory Agencies before, during and after approval.Support project management of e-Submission , including communication with sponsors, upper managemnet and colleagues.

Braunschweig Area, Germany

Pune Area, India

Assistant Professor in Microbiology. Lectures and practicals for post graduate students in Pharmaceutical Microbiology, Biostatistics, Molecular Biology; Fermentation Technology, Bioinstrumentation & Biochemistry. Guided over 25 students for their Master's dissertation, with successful publications.

Braunschweig Area, Germany

Natural Product Research and Drug Discovery. • Research on biologically active natural products from fungi as candidates for anti-infective drugs.• Screening and identification of producers, growth, downstream processing,natural product chemistry and evaluation of bioactive potential

University Of Pune

Visiting Assistant Professor in Biostatistics for five year integrated Masters Programme

Ph.D in Microbiology

Pune Area, India

Research and development, production and quality control of biofertilizers, biocontrol agents, compost accelerators for a specialized agri-biotech company.

Pune, Maharashtra, India

Lecturer in Microbiology: Strong focus on Industrial Microbiology, Applied microbiology and Biochemistry

Clinical Research And Monitoring, Clinical Research, Data And Project Management, Regulatory Affairs, Study Documentation,Qa/Qc., O (85%)

Clinical research, Data management, Regulatory affairs, GCP-ICH, AMG, GCP-V, Declaration of Helsinki, Project management, Study.

German B2, Language Course, A+

B2.1, German Language And Literature

Doctor Of Philosophy (Phd), Microbiology, General

Master Of Science (M.Sc.), Microbiology, General