לוח משרות דרושים רפואה ופארמה במרכז

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.
Home Based role requiring experience with both submissions and contract negotiations within Israel as well as fluency in Hebrew.
Essential Functions
Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
Distribute completed documents to sites and internal project team members.
Prepare site regulatory documents, reviewing for completeness and accuracy.
Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
Review and provide feedback to management on site performance metrics.
Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
Inform team members of completion of regulatory and contractual documents for individual sites.
Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
Perform quality control of documents provided by sites.
May have direct contact with sponsors on specific initiatives.

we are transforming the delivery industry by making drone delivery a real-world, scalable solution. We are looking for a Regulatory Affairs Lead to join the company regulation team and play a key role in major regulatory and compliance efforts that support the certification of advanced UAS platforms and the execution of groundbreaking operational projects. You will be part of a fast-growing company, working with a highly multidisciplinary team in a dynamic environment in the heart of Tel Aviv. In this role, you will support and lead regulatory activities related to the certification, approval, and operation of our companys UAS platforms. Working at the intersection of regulation, operations, engineering, and business, you will interpret complex regulatory frameworks, help shape compliance strategies, and support engagements with aviation authorities and other relevant bodies. You will collaborate closely with cross-functional teams to translate regulatory requirements into practical internal guidance, documentation, and processes that support safe, compliant, and scalable real-world operations. Main Responsibilities
* Review, interpret, and monitor aviation regulations, standards, and policy developments relevant to the companys activities.
* Support and lead regulatory approval efforts with aviation authorities and other relevant organizations.
* Assess the impact of regulatory requirements on company operations, products, and processes, and recommend appropriate actions.
* Prepare, review, and manage regulatory documentation, including manuals, position papers, internal guidance materials, filings, presentations, and compliance records.
* Collaborate with cross-functional teams, including product, engineering, operations, and management, to develop and implement processes and procedures that support regulatory compliance across the organization.
* Prepare and submit regulatory filings, applications, permits, and other documentation required by regulatory agencies, ensuring accuracy, consistency, and adherence to deadlines.
* Track industry trends, evolving standards, and emerging regulatory issues in order to identify compliance risks and support proactive mitigation strategies.