Head of Regulatory Affairs Quality

Bachelor's degree or higher in Pharmacy, Life Sciences, or a related fieldMinimum of 5 years of experience in regulatory affairs in the pharmaceutical or medical device industryStrong knowledge of local and international regulations governing pharmaceuticals and medical devicesExperience in preparing regulatory submissions and filingsExcellent...

· Responsible for the coordination of submissions to Regulatory Authorities and Ethics Committees in the assigned regions and ensures quality of regulatory documentation· Provides regulatory support regarding start up activities and maintenance in the assigned clinical projects and advice to local project teams and key internal/external...

Reviewing quality specifications and technical design documents to provide timely and meaningful feedback Creating detailed, comprehensive and well-structured test plans and test cases Estimating, prioritizing, planning and coordinating quality testing activities Design, develop and execute automation scripts using open source tools Identify,...

Regulatory Expertise: Leverage your in-depth knowledge of European regulations to contribute to the development of high-quality regulatory documents, including but not limited to clinical study reports, regulatory submissions, protocols, investigator brochures, and marketing authorization applications.Technical Mastery: Dive into the technical details of...

Provide strategic leadership and direction for all medical affairs activities, including clinical development, regulatory affairs, and pharmacovigilance for a Phase 2 ALS programEstablish and nurture collaborative partnerships with key stakeholders, including, regulatory agencies, and clinical research organizations.

Join a software dev company top-ranked by and DOU and pump up your skills by working with some of the brightest tech experts across four continents.With us, you canWork in a dream team of A-playersKnow that your opinion mattersEnjoy flexibility by operating remotely or onsite in our R&D centersShape your professional journey through a personalized growth...

Conduct regular inspections and audits to identify and resolve any potential quality and safety issues.Maintain accurate records of quality control measures and compliance with regulatory requirements.Collaborate with internal teams to implement and improve quality and safety protocols.Participate in testing and analysis, ensuring the highest standards are...

Perform quality inspections and tests on incoming materials, in-process production, and finished products/services.Identify and report any deviations from quality standards and work with relevant teams to address and resolve issues.Develop and implement quality control procedures and protocols to ensure compliance with regulatory requirements and customer...

A minimum of 3 years of leading Manufacturing & R&D sites.Experience leading finances for Regulatory & Quality and Commercial departments globally.A minimum of 3 years of management experience.Strong understanding of accounting.Hebrew speakers are preferred.Start-up experience is preferred.

Should be able to demonstrate strong understanding of USFDA/ MHRA/ EU or local guidelines.Responsible for setting strategy direction for the entire Quality Control & Microbiology Department and team.Conducts performance reviews for teamsDevelopment, review, revise and implementation of Standard Operating Procedures (SOPs)/ Standard Test Procedures...

• Prepare and execute the Quality Control Program on site• Inspect and perform testing coordination and control• Supervise workers engaged in inspection and testing activities to ensure high productivity and high technical integrity• Formulate, document and maintain quality control standards and on-going quality control objectives•...

On behalf of a global PMC company, Petroplan are seeking a Head of Instrumentation to be based in Kuwait. This will be offered on a long term renewable contract working in their major projects division.Responsiblity:Manage the team of Leads Engineers.Resolve technical problems, and guide a team of engineers through all stages of projects.Review and approve...

On behalf of a global PMC company, Petroplan are seeking a Head of Instrumentation to be based in Kuwait. This will be offered on a long term renewable contract working in their major projects division. Responsiblity:Manage the team of Leads Engineers.Resolve technical problems, and guide a team of engineers through all stages of projects.Review and approve...

Strategic Planning:Develop and implement engineering strategies in alignment with the organization's overall goals and objectives.Provide technical leadership in the development of long-term plans and strategies for the engineering department.Project Management:Oversee the planning, execution, and completion of engineering projects.Ensure that projects...

On behalf of a global PMC company, Petroplan are seeking a Head of Process Engineer to be based in Kuwait. This will be offered on a long term renewable contract working in their major projects division.Responsiblity:Manage the team of Leads Engineers.Resolve technical problems, and guide a team of engineers through all stages of projects.Review and approve...

On behalf of a global PMC company, Petroplan are seeking a Head of Process Engineer to be based in Kuwait. This will be offered on a long term renewable contract working in their major projects division. Responsiblity:Manage the team of Leads Engineers.Resolve technical problems, and guide a team of engineers through all stages of projects.Review and approve...

Develop and manage relationships with public relations agencies and other outside companies in the development of programs to meet communications objectives.Promote teamwork and quality service through daily communication and coordination with other departments. Key departmental contacts include sales and revenue, F&B and other departments, hotel Executive...

Implement and administer Ora document management systems (Veeva Vault) and related procedures that allow Ora staff to capture, store, retrieve, share, and destroy electronic records and documents in a manner consistent and in accordance with SOPs, ICH GCP guidelines, FDA, and EU Directive (and other global regulatory agencies as needed).Manage documentation...

Performance Evaluation and Improvement:Conduct post-training evaluations to assess the impact of training on employee performance.Analyze training outcomes and identify areas for improvement or modification.Recommend adjustments to training programs based on feedback and evaluation results.Compliance and Reporting:Ensure training programs comply with...

Planning & Execution: Develop production plans, oversee technical elements, and ensure seamless event execution.Budget & Vendor Management: Manage budgets, negotiate with suppliers for cost-effective solutions.Team Leadership: Lead and motivate production teams for successful event delivery.Quality Control & Compliance: Implement quality measures, ensure...