CMC Regulatory Affairs Specialist in (

A leading Med-Tech company is looking for a CMC Regulatory Affairs Specialist to join our team and support the development and implementation of the company's regulatory effort. Location: Central Israel Position Type: Full-time, Sunday-Thursday Job Responsibilities: • Prepare, compile, and update CMC sections of IND (FDA) and IMPD (EU) submissions, including amendments, annual reports, and responses to questions from health authorities. • Manage the day-to-day regulatory affairs activities for specific projects to achieve company and RA department objectives. Ensure consistency, completeness, and adherence to standards for all regulatory submissions. • Collaborate with the clinical team to ensure the investigational materials meet regulatory requirements for clinical studies intended for submissions. • Assist and provide guidance on developing and maintaining CMC-related SOPs, including change control procedures and stability protocols, regulatory risk assessments for manufacturing, supply chain, and testing to ensure compliance with ICH guidelines and propose mitigation strategies. • In charge of compiling and maintaining a regulatory-compliant Drug Development File. • Maintain the electronic/paper regulatory archives for all projects, including health authority correspondence. • Keep up to date with changes in regulatory legislation and guidelines. • Review and supervise vigilance activities and documentation. • Outline requirements for labeling and packaging. Position Requirements: • Relevant degree in life or medical sciences. • Minimum 3 - 5 years of experience in CMC regulatory affairs from the pharmaceutical industry, preferably for drugs in the clinical development stage. • Advanced knowledge of US drug regulation, CMC. • Experience in combination drug-device products or previous professional experience in the medical devices industry - an advantage. • US Drug for inhalation and Botanical drug - an advantage. • Familiarity with European (preferably MDR) medical device regulation, and Canadian and US medical device regulations - an advantage. • Ability to work independently with minimal direction or within project teams to attain group goals. • Ability to creatively complete activities within aggressive time schedules. • Excellent communication skills and ability to collaborate with team members and external stakeholders. • Fluent in English and excellent writing skills. המשרה פונה לגברים ונשים, כאחד.