לוח משרות דרושים רישום / רגולציה רפואית משרה מלאה

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.

Join our Israeli Regulatory team as a Regulatory Affairs Manager and Appointed Pharmacist responsible for the registration and maintenance of Marketing Authorizations for medicinal products of assigned portfolio and related health regulated activities. You will be also involved in transversal regulatory activities in dedicated projects.

The team is involved in developing regulatory product strategies, leading regulatory efforts in the development stage and post marketing of drug products in the Israeli market.

Main responsibilities:

Serve as Appointed Pharmacist, responsible for all matters related to medical products as specified by the Ministry of Health
Ensure compliance with local Israeli regulations and requirements
Manage regulatory aspects of product lifecycle from development through post-marketing including:
- Define registration and maintenance plans
- Coordinate country dossier preparations
- Manage registration, renewal, and post-authorization variation processes
- Update product labels and packaging materials
- Contributing to the Global Regulatory Product Strategy
Review promotional and non-promotional materials for regulatory compliance
Implement processes and quality systems
Monitor changes in the regulatory environment in Israel
Build strong external network with Health Authorities and Trade Associations

Join us in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.

As a Quality Assurance in Israel, you will ensure compliance with global quality standards through documentation management and process control. You will oversee training programs, monitor quality metrics, and manage local GxP subcontractor oversight. You will drive continuous improvement through risk management and quality audits to maintain the highest standards of quality assurance

Main responsibilities:

Support the maintenance of Country Quality documentation management system in compliance with global procedures and quality standards.

Deviation and Corrective-Preventive Actions (CAPA) management: maintain the process to manage deviations and CAPAs related to all GxP and health-regulated activities

Change Control management: maintain the process to manage the changes that may impact GxP or health-regulated process or operations by leading multidisciplinary exchanges and action plans when necessary

Training: organize and manage information sharing, training sessions or programs related to processes owned by the Quality unit for concerned country associates, according to our standards and regulatory requirements

Country Quality Review: Monitor the related Quality Program and Action Plan follow-up

Country Quality performance indicators (KPIs): periodically report country KPIs defined by Global Quality

Support Quality oversight of locally managed GxP subcontractors: ensure an appropriate quality oversight process of locally managed subcontractors

Quality risk management: Ensure that quality risks are properly managed within the country (identification, assessment, control, communication)

Organize and participate in self-inspections, internal audits and external audits of third parties (suppliers / distributors / carriers / etc.) in accordance with the approved annual plan.

Assist in preparing, creation and maintenance regulatory documentation for FDA and CE submissions. Flexible working hours to accommodate academic schedules. Opportunity to gain hands-on experience in the medical device regulatory field.

What you will be doing:
* Provide regulatory support to the Development and Post marketing activities related to our products.
* Preparation and maintenance of regulatory submissions and registrations of our products in relevant markets.
* Review complex reports, validations, etc. for scientific merit and regulatory appropriateness; Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
* Preparation and maintenance of annual renewals of Establishment Registrations, Device Listing, and other pertinent regulatory licenses.
* Review of customer complaints to determine reportability according to regulatory requirements and execution of reporting per determination.
* Provide ongoing regulatory support and assessments to different QMS related processes (e.g. MRB, CAPA, Contract review)
* Actively participate in the evaluation of changes to the QMS documents and device design/process for impact on pending or existing registrations
* Provide support for all external/internal audits at HQ and globally, as needed
* Advise project teams on premarket regulatory requirements, labeling requirements and/or other compliance issues.
* Work closely with various other teams (e.g. R&D, Operations, Quality, Marketing) both locally and around the world, to provide regulatory inputs as needed.
* Monitor and advise the organization of upcoming or new guidance, regulations, agency/industry initiatives, etc. to ensure ongoing regulatory compliance
* Attend other regulatory related needs, as required
* Working according to our Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules.

We are looking for a Regulatory & Safety Manager.
This pivotal Regulatory Manager role offers you the opportunity to champion collaboration across teams, enhancing your leadership abilities. As the bridge between Reckitt and regulatory agencies, your expertise will be key in guiding our innovative products through complex regulatory landscapes to reach consumers safely and efficiently.
Your responsibilities:
Manage and coordinate all aspects of regulatory affairs on full portfolio
Responsible for local regulatory team including Development plan, Growth and proper knowledge and expertise
Ensure all registration objectives financial targets are met
Ensure full compliance with local & global requirements towards regulatory activities
Effectively manage Pharmacovigilance
Have responsibility for defining and adapting regulatory strategies and implement them across defined categories
Complying with Global standards and local procedures and help providing safe, effective and compliant products to customers, consumers and patients.