Regulatory Affairs Manager

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...

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.

A minimum of 3 years of management experience.7+ Years of experience with global submissions with Class III devices.Strong understanding of MDR regulations.Hebrew speakers are preferred.Start-up experience is preferred.

Accountable for the overall planning, reporting, and execution of one or more projects per an agreed scope, target profile, timelines and budget.Leads the project team(s) to create the project strategy and the plans for each phase of the project (feasibility, research, development, through registration and launch), in collaboration with the technical leads...

Marketing plan: You will create, partnering with the EMEA and cross functional leadership team, and action the 5 year strategic plan as well as the annual marketing plan that drives Aerogen towards standard of care with sustained double digit revenue growth, while maintaining margins and delivering increased market share.Team development: You will lead a...

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...

Quality Manager, Kuwait Are you motivated by creating visible results? Are you enthusiastic about understanding the business and the people and driving innovation for the life-changing benefit of patients? Then, this is your moment to take the next step in your professional development in a globally expanding company. Join Novo Nordisk, Kuwait as...

Develop and lead the monitoring and continuous improvement of the QMS compliant with relevant global jurisdictional medical device requirements.Audit, qualification and review of key service providers, manufacturing partners and supply chain. Serve as Management Representative in any audit by a regulatory authority / Notified Body and lead all audit...

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...

As Certification & Safety Manager, you will be responsible for overseeing all aspects of certification and safety for our air mobility products, including strategy development, coordination with regulatory bodies, and ensuring compliance with safety standards. You will play a critical role in building and leading a capable certification team, fostering...

Drive continuous improvement initiatives to enhance supply chain performance, including inventory management and cost optimization.Analyze market trends and supplier capabilities to identify strategic opportunities and mitigate risks.Ensure compliance with regulatory requirements and company policies in all supply chain activities.

• Advise the client on energy supply management strategies and implement commodity risk policies, active risk management and hedging as well as renewable purchasing programmes• Provide insight and market intelligence to customers in the form of reports, meetings and presentations with support of regional Advisory Services’ consultants for...

QHSE Strategy and Policy Development:Develop, implement, and continuously improve QHSE strategies, policies, and procedures in alignment with industry best practices and regulatory requirements.Drive a culture of safety, quality, and environmental stewardship across all levels of the organization. Risk Management and Compliance:Identify, assess, and mitigate...

The purpose of the role is to maximize the financial performance of the property portfolio, maintaining the buildings according to accepted business standards and managing tenants and staff.Financial performance of the PortfolioPrepare and refine portfolio budgets in line with agreed assumptions and other relevant information to determine the targets to be...

Management of Consumer Marketing GROW Activities. Deliver the Customer base revenue as outlined in the Annual Budget from the various retention related activities.Oversee the rollout of various customer growth activities, which are designed to increase Life Time Value, and improve the Life Cycle Management process for our customers. Segment offering...

- Implementing personal affairs services activities for the Human Resources Department related to employee files, attendance, dismissal, retirement, resignation, termination, handling complaints, conflicts of interest, taking disciplinary actions, advances, employee advances, benefits, benefits management, and other employee administrative management...

In this role, you will: Provide legal advice and guidance on all topics under the scope of regulatory compliance with an emphasis on Anti-Bribery, Export Control, Sanctions, and evaluating potential legal risksMonitor legislative developments in relevant compliance areas and implement new legal requirements, including in the field of AI.Develop, implement,...

Bachelor’s degree in life/health sciences or related discipline, or equivalent required.6 to 8 years of relevant clinical research experience in a Clinical Research Organization/Pharmaceutical Company, with a minimum of 3 years of Project Management experience in a CRO or pharmaceutical company required. Other professional and/or educational experience...

Overseeing Accounting Operations: Manage all aspects, including Billing, A/R, A/P, GL, Cost Accounting, Inventory Accounting, and Revenue Recognition.Leading Budget and Financial Forecasts: Direct the preparation of our budget and financial forecasts, reporting on variances.Publishing Monthly Financial Statements: Ensure timely preparation and dissemination...