Planned and managed regulatory activities in collaboration with the RA team. Communicated with regulatory agencies and consultants to ensure alignment with compliance standards. Coordinated, prepared, and reviewed regulatory submissions and documents for FDA, EMA, and other authorities. Provided regulatory guidance to functional teams to maintain compliance with the company’s evolving activities.Formerly employed by Chiasma Inc. Aug-2021 acquired by Amryt Pharma plc.

Regulatory Affairs consultant for global pharma and medical device companies, working with the Israeli MOH.

Developed and executed regulatory strategies, managed regulatory submissions and FDA communications as part of a comprehensive regulatory strategy. Prepared and submitted regulatory documents such as DSURs, meeting packages, orphan drug designations (US/EU), clinical and preclinical protocols, and IND amendments.

Led Regulatory Affairs operations at Isorad ltd., specializing in Nuclear Medicine and Radiopharmaceuticals. Ensured regulatory compliance for aseptic manufacturing processes, development and lifecycle management of SPECT and PET diagnostics (e.g. Technetium-99m generator, Gallium citrate Ga-67, Thallium chloride Tl-201 etc.) and MRI Gd-DTPA contrast agents.

Regulatory affairs for class II (US) & class IIb (EU) medical products: laser, intense pulsed light (IPL), radio-frequency (RF) for surgical, ophthalmology and aesthetic procedures.Providing on-going regulatory strategy and support to R&D and Business teams.Reviewing and recommending changes for labeling and marketing literature for regulatory compliance.

Interaction with international health authorities obtaining marketing authorizations.Management of regulatory strategy, representing the company with EU, and Israeli RA agencies.Regulatory follow-up of products from the development stage, close collaboration with R&D, QC, QA, Engineering, Marketing and Sales concerning regulatory requirements.Writing and reviewing products information documents including SmPC, patient leaflet, and labeling

Microbiological monitoring of pharmaceutical products, validation of analytical methods, writing SOPs, initiating and developing analytic methods' validation.