דרושים » רפואה ופארמה » מוביל רגולציה /Regulatory Affairs Lead

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 25 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 are looking to make a difference in people's lives, we invite you to join us! We are hiring PV Associate. Monitoring and reporting adverse events and safety information, ensuring compliance with regulatory safety guidelines and conducting activities to monitor and enhance the safety profile of Medison’s products

Responsibilities:

* Receiving, translating, processing and documenting any reports, from overseas or locally, regarding adverse events and safety information of Medison’s products in compliance with regulatory requirements
* Submitting timely and accurately safety reports to the Ministry of Health in compliance with local regulatory requirements
* Actively following-up on adverse events reported by physicians and patients
* Collecting and reviewing safety and efficacy measures taken by health authorities in recognized countries. This includes monitoring publications, regulatory updates, and safety communications from agencies such as the FDA, EMA, and other global health organizations to ensure compliance and up-to-date safety practices for Medison’s products
* Reviewing relevant data from the scientific literature related to drug safety. This includes conducting literature searches to identify new safety information, adverse events, and emerging safety issues
* Promoting awareness among healthcare professionals and medical teams regarding the importance of reporting adverse events to ensure public safety
* Conducting periodic internal and external reconciliations
* Assisting in preparation for PV audits and inspections
* Conducting PV trainings to Medison’s employees and external suppliers
* Additional tasks as defined by the manager

we offer 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 25 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 are looking to make a difference in people's lives, we invite you to join us! As a QP Pharmacist, you will be Responsible for ensuring compliance with all ongoing control processes designed to guarantee that products are not released to the market until it is determined that their quality matches the approved specifications in the registration file. In addition, responsible for quality processes in the regulatory affairs department that will be adapted to international standards, local regulations, where applicable, and the organizational quality level established for medical products. This is a temporary position for 8 months.
Responsibilities:

* Qualified Person Responsible Pharmacist of the importer.
* Ensuring Compliance with Israeli Regulations: The QP is responsible for ensuring that all pharmaceutical products meet the standards set forth by Israel's Ministry of Health (MoH) and other relevant regulatory authorities. Review the product batch release documentation and authorizing or rejecting the batch release to the market. Certification of Compliance: to certify that each batch of the product has been produced and tested according to relevant specifications and regulations before it reaches the market.
* Accompanying regulatory audits and being responsible for regulatory knowledge, document control, writing procedures, maintaining and updating relevant professional literature, and assisting in planning training activities in the field.
* Liaison with the MOH and working according to the MOH guidelines, including immediate reporting of any complaint or recall if necessary.
* Responsible for batch releases of registered and non-registered products.
* Review PQRs and full batch records provided by the partners.
* Execution of additional supervisors instructions and tasks accordingly.

We are seeking a highly skilled Technical Lead to own regulatory compliance aspects within our software development lifecycle, along with the detection, evaluation, and management of open-source initiatives across the organization. This role sits within the CTO office and reports directly to the Director of Architecture.
What am I going to do?
Regulatory Compliance:
Own and oversee technical compliance with key regulatory frameworks including GDPR, SOC2, and privacy/user safety regulations.
Work closely with development and product teams to ensure software development processes and products meet regulatory standards.
Proactively identify compliance risks and recommend solutions.
Facilitate audits and assessments by providing detailed documentation and evidence.
Open Source Management:
Identify opportunities within the organization to develop and release software as open source.
Manage and oversee licenses for open-source software developed by the company, ensuring compliance with legal and regulatory standards as well as company IP requirements.
Take responsibility for open-source creation and release lifecycle, including quality and standards validation, versioning, release management, feedback collection, contribution and attribution management, documentation management, and public announcements.
For each open-source initiative, maintain a clear and public roadmap aligned with our companys goals and objectives.
Maintain and cultivate the community surrounding our companys open-source projects, encouraging collaboration and contribution.
Develop strategies, process and tooling to efficiently manage open-source project lifecycles.
Technical Leadership:
Serve as a hands-on technical expert, reviewing, validating, and participating in code contribution across multiple projects.
Provide mentorship to developers and promote best practices around regulatory compliance and open source utilization.
Engage with cross-functional teams to advocate and implement secure and compliant technical architectures.