לוח משרות דרושים רישום / רגולציה רפואית, לחיפוש זה נמצאו 23 משרות

Medison offers hope to patients suffering from rare and severe diseases by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets. As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead and work relentlessly to bring therapy to patients in need, no matter where they live. Our values are at the core of every action we take, and we are committed to going above and beyond for the benefit of the patients we serve. We are a dynamic, fast-paced company operating in over 30 countries on 5 continents. We are looking for out-of-the-box thinkers, people who are passionate, caring, agile, and adaptive, to join us on our mission. If you want to make a difference in people's lives, we invite you to join us! The Regulatory Affairs Appointed Pharmacist will supports all Regulatory Affairs activities, including but not limited to preparation of registration dossiers, ensuring compliance with regulatory requirements, drafting product documentation, developing patient leaflets, overseeing packaging design, and managing updates to product labeling.

Responsibilities:

* Provide professional regulatory advice to Medison’s business units and partners.
* Planning and executing regulatory activities, periodic updates of approved dossiers and managing the change control process for pharmaceutical products.
* Good relationships with regulatory authorities and Medison’s partners and advancing timelines in the registration processes.
* Preparing registration dossiers, including content verification according to SOPs, submission, and tracking of registration dossiers with the Ministry of Health.
* Preparing packaging materials, including review and submission in accordance with the Ministry of Health requirements and in compliance with the product's registration
* conditions.
* Handling all types of submissions, new products, changes, and renewals.
* Ensuring that publications intended for the medical staff comply with Ministry of Health requirements and adhere to the product's registration conditions.
* Preparing registration dossiers for medical devices, including submitting registration applications, renewing licenses according to SOPs, and supporting the company's
* medical equipment and devices unit with registration requirements.

City:
Petah Tikva

we are looking for a Country Approval Specialist.
As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals. This opportunity is an exciting prospect for a big pharma company and for a new division focused on Oncology/Cell therapy
What Youll Do:
Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
Provides project specific local SIA services and coordination of these projects.
May have contact with investigators for submission related activities.
Key-contact at country level for either Ethical or Regulatory submission-related activities.
Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
Achieves PPDs target cycle times for site.
May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
May develop country specific Patient Information Sheet/Informed Consent form documents.
May assist with grant budgets(s) and payment schedules negotiations with sites.
Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
Entes and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

we are looking for a Principal Medical Writer (Publications).
The Publications and Scientific Communications team, a part of Medical Writing and Healthcare Communications, prepares medical publications, abstracts, posters, presentations, and other scientific communications. Our dynamic, highly collaborative team focuses on providing quality writing to internal collaborators and external pharmaceutical and biotech clients.
A day in the life:
Write, edit, and handle publications and other scientific communications (manuscripts, posters, abstracts, oral presentation slide decks, and review articles), on time, within budget, and with little instruction. Provides senior review of documents.
Appropriately resolve or raise project management issues, such as out-of-scope activities
Ensure compliance with quality processes and requirements
Represent the team as a prime contact on projects, establishes clients relationships.
Assist in business development initiatives
Lead or provide input on initiatives for process improvement, provides training and mentorship of other writers.

Required Regulatory Affairs Appointed Pharmacist, Israel
The Regulatory Affairs Appointed Pharmacist will supports all Regulatory Affairs activities, including but not limited to preparation of registration dossiers, ensuring compliance with regulatory requirements, drafting product documentation, developing patient leaflets, overseeing packaging design, and managing updates to product labeling.
Responsibilities
Provide professional regulatory advice to our business units and partners.
Planning and executing regulatory activities, periodic updates of approved dossiers and managing the change control process for pharmaceutical products.
Good relationships with regulatory authorities and our partners and advancing timelines in the registration processes.
Preparing registration dossiers, including content verification according to SOPs, submission, and tracking of registration dossiers with the Ministry of Health.
Preparing packaging materials, including review and submission in accordance with the Ministry of Health requirements and in compliance with the product's registration
conditions.
Handling all types of submissions, new products, changes, and renewals.
Ensuring that publications intended for the medical staff comply with Ministry of Health requirements and adhere to the product's registration conditions.
Preparing registration dossiers for medical devices, including submitting registration applications, renewing licenses according to SOPs, and supporting the company's
medical equipment and devices unit with registration requirements.

Required QPPV, Israel
The QPPV is a senior position within the pharmacovigilance team, responsible for ensuring that we comply with all regulatory requirements related to the safety of its medicinal products. The QPPV is the primary point of contact for the Israeli MoH and our global partners and ensures that we meet our legal obligations regarding the monitoring, assessment, and reporting of adverse drug reactions
Responsibilities
Communicating with the Ministry of Health regarding pharmacovigilance activities, ensuring compliance with local regulations. This includes timely submission of safety reports and responding to inquiries and requests
Overseeing the internal PV system, ensuring its effectiveness and continuous improvement, including processes, tools, and personnel
Managing the safety agreements with our global partners and external suppliers, if applicable
leading PV audits conducted by our global partners and inspections conducted by the Ministry of Health
Communicating with our global partners, including participation in periodic meetings, as required
Monitoring the compliance of our employees with internal procedures, including corrective actions as needed
Collaborating with internal departments such as Regulatory Affairs and Medical Affairs to address pharmacovigilance issues
Ensuring coordination with the Quality Assurance team to ensure pharmacovigilance processes align with company standards
Additional tasks as defined by the manager.

Flytrex is transforming the delivery industry by making drone delivery a real-world, scalable solution. We are looking for a Regulatory Affairs Lead to join the Flytrex 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 Flytrex’s 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 company’s 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.