תיאור המשרה, כולל ציון המיקום שלה
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.
