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Regulatory Affairs Manager – International Regulatory Affairs
CytoSorbents, a critical care leader specializing in blood purification and blood products technologies to treat critically ill, injured, and surgical patients, is seeking a Regulatory Affairs Manager with experience in International Regulatory Affairs.
The Regulatory Affairs Manager in International Regulatory Affairs will be responsible for submission of Int’l Marketing Authorization Applications. They will contribute to regulatory submission strategy, identifying submission risks and opportunities, while leading international regulatory applications through approval and providing regulatory expertise and guidance on procedural and documentation requirements for international markets and working flexibly within and across regions to ensure the fulfilment of business objectives.
We are seeking someone with project management capabilities who will be responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables, including delivery as an individual contributor.
Come join us in saving lives!
- The Regulatory Affairs Manager in International Regulatory Affairs is fully proficient in applying established standards.
- Responds to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information to affiliates.
- Provides regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s).
- Submission delivery strategy for technical dossiers to multiple international markets and /or regions.
- Contribute to and review of response documents.
- Contributes to development and review labeling compliant to international markets and / or regions.
- Works closely with countries’ / regions representatives.
- Uses and shares best practices, when handling various applications during interactions with health authorities and in day-to-day work.
- Liaises closely with cross-functional team members with aligned product responsibilities.
- Develops, executes, and maintains regulatory submissions, and proactively provide status updates to designated stakeholders.
- Coordinates the input and revision of project plans for assigned projects and highlights unforeseen changes in resource demand in a timely manner.
- Understand the regulatory framework, including regional trends.
- Identifies regulatory risks and propose mitigations to leadership and cross functional teams.
- Supports operational and compliance activities including submission tracking, utilizing the support and input of cross-functional teams, where relevant.
- Provides coaching, mentoring and knowledge sharing on international markets within the regulatory organization.
- May facilitate strategic input. Participates in continuous improvement.
- Occasional travel to NJ office.
- Other duties as assigned.
- Degree in Science or related discipline along with a minimum of 5 years of relevant Regulatory experience within the medical device industry.
- General knowledge of product development and strong project management skills.
- Leadership skills, including experience leading multi-disciplinary project teams.
- Regulatory affairs experience across a broad range of markets.
- Managed regulatory deliverables at the project level.
- Experience of working with country representatives in the international regions.
- Capable of leading cross functional activities and performing Regulatory Affairs Management for International market submissions under minimal supervision.
- Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions.
- Proficiency with common project management (e.g., MS Project) and document management tools.
- Excellent English written and verbal communication skills.
- Ability to work independently and as part of a team.
- Influencing and stakeholder management skills
- Ability to analyze problems and recommend actions.
- Covid vaccination required.
Job posted: 2023-04-25