אתר sababajobs סבבה ג'ובס - פורטל דרושים
סבבה ג'ובס - למצוא את העבודה שתעשה לך סבבה!
מיקום המשרה: תל אביב יפו
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.
* משרה מס׳ #486010 מיועדת לגברים ונשים כאחד