Regulatory Operations Director
5 days ago
Cg Oncology, Inc. is seeking a highly skilled Regulatory Operations Director to join our team. As a key member of our regulatory operations function, you will be responsible for providing strategic leadership and direction to ensure the successful planning, preparation, and publishing of electronic submissions to domestic and foreign regulatory agencies.
Key Responsibilities:- Submission Planning and Preparation: Develop and implement submission plans, ensuring timely and accurate submission of regulatory documents to domestic and foreign regulatory agencies.
- Regulatory Operations Leadership: Provide strategic direction and leadership to the regulatory operations function, including management of publishing vendors and coordination with cross-functional teams.
- Regulatory Expertise: Provide regulatory expertise and interpretation of submission requirements and technical guidance to team members and serve as a representative to regulatory agencies on technical aspects of eCTD filings.
- Submission Tracking and Management: Maintain the submission-tracking process in support of short and long-term submission and resource planning.
- System Ownership: Serve as system owner for regulatory information tools and systems, including eCTD publishing tools, electronic document management system (EDMS), library system, and electronic templates.
- Education: Bachelor's degree in a relevant scientific field or equivalent experience.
- Experience: Ten (10) years of progressive managerial and regulatory operations experience at a high-growth pharmaceutical/biotechnology company, with experience in a complex therapeutic area (e.g., oncology, virology, etc.).
- Regulatory Knowledge: Demonstrated understanding and strategic application of submission regulations and guidelines for drug development at IND and NDA/BLA stages, including familiarity with international regulatory requirements and documentation.
- Communication Skills: Excellent communication and leadership skills, with the ability to travel to visit external vendors/partners and attend relevant conferences or meetings within and outside of the United States.
- Competitive Salary: $205,000-$220,000 per year, depending on experience and qualifications.
- Total Rewards Package: Comprehensive benefits package, including health insurance, retirement plan, and paid time off.
- Opportunities for Growth: Career advancement opportunities within a dynamic and growing company.
Cg Oncology, Inc. is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating a workplace that is inclusive and respectful of all employees. If you are a motivated and experienced professional looking for a new challenge, please submit your application today.
-
Regulatory Operations Director
5 days ago
Irvine, California, United States CG ONCOLOGY INC Full timeJoin Our Team as a Director of Regulatory OperationsCG Oncology Inc. is seeking a highly skilled and experienced Director of Regulatory Operations to join our team. As a key member of our regulatory operations team, you will be responsible for providing strategic leadership and direction in the development and implementation of regulatory strategies to...
-
Director of Regulatory Operations
4 days ago
Irvine, California, United States CG ONCOLOGY INC Full timeJoin Our Team as a Director of Regulatory OperationsAt CG Oncology, we are seeking a highly skilled and experienced Director of Regulatory Operations to join our team. As a key member of our regulatory operations team, you will be responsible for providing strategic leadership and direction in the planning, preparation, and publishing of electronic...
-
Director of Regulatory Operations
3 weeks ago
Irvine, California, United States CG ONCOLOGY INC Full timeJoin Our Team at CG Oncology Inc.We are seeking a highly skilled and experienced Director of Regulatory Operations to join our team at CG Oncology Inc. As a key member of our regulatory operations team, you will be responsible for providing strategic leadership and direction in the planning, preparation, and publishing of electronic submissions to domestic...
-
Regulatory Affairs Director
5 days ago
Irvine, California, United States Diality Full timeJob Title: Director of Regulatory AffairsDiality Inc, a privately held medical device company, is seeking a highly skilled Director of Regulatory Affairs to oversee the development and implementation of regulatory strategies for our innovative hemodialysis machine. As a key member of our team, you will be responsible for ensuring compliance with global...
-
Regulatory Affairs Director
5 days ago
Irvine, California, United States Diality Full timeJob Title: Director of Regulatory AffairsCompany Overview:Diality Inc, a privately held medical device company, is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel.Job Summary:The Director of...
-
Irvine, California, United States AbbVie Full timeAbout AbbVieAbbVie is a leading global biopharmaceutical company that discovers and delivers innovative medicines and solutions to address serious health issues.Job DescriptionThe Director of Regulatory Affairs and Strategic Labeling will play a critical role in setting strategy and leading cross-functional teams to execute labeling activities for drugs,...
-
Regulatory Operations Specialist
4 weeks ago
Irvine, California, United States Planet Pharma Full timeJob Title: Sr. Regulatory Operations SpecialistJob Summary:We are seeking a highly skilled Sr. Regulatory Operations Specialist to join our team at Planet Pharma. As a key member of our regulatory operations team, you will be responsible for leading the submission content management, submission publishing in US & EU, regulated master data management...
-
Regulatory Affairs Director
3 weeks ago
Irvine, California, United States DIALITY INC Full timeJob DescriptionDiality Inc, a pioneering medical device company based in Irvine, CA, is dedicated to revolutionizing the treatment of kidney disease. Our cutting-edge, portable hemodialysis machine will empower patients to self-treat at home or on-the-go, breaking free from the constraints of traditional dialysis methods. As a key member of our team, you...
-
Director of Operations
3 weeks ago
Irvine, California, United States Finfare Full timeJob Title: Director of OperationsFinfare is seeking a highly skilled Director of Operations to join our team. As a key member of our leadership team, you will be responsible for developing and executing the operational strategy in alignment with the company's overall objectives and growth plans.Key Responsibilities:Operational Strategy and Planning: Develop...
-
Regulatory Operations Specialist
3 days ago
Irvine, California, United States Entegee Full timeJob SummaryEntegee is seeking a highly skilled Regulatory Operations Specialist to manage submission publishing, device listings, and UDI data collection for medical devices in the US and EU markets.Key Responsibilities:Lead submission content management and submission publishing for US and EU marketsManage regulated master data, including UDI data...
-
Director of Operations
2 weeks ago
Irvine, California, United States Finfare Full timeJob Title: Director of OperationsFinfare is seeking a highly skilled and experienced Director of Operations to join our team. As a key member of our leadership team, you will be responsible for developing and executing the operational strategy in alignment with the company's overall objectives and growth plans.Key Responsibilities:Develop and execute...
-
Financial Operations Director
4 weeks ago
Irvine, California, United States Sonesta International Hotels Corporation Full timeAccounting Manager Job DescriptionThe Accounting Manager plays a crucial role in supporting the Director of Finance by overseeing and performing various financial functions related to accounting, internal control, and financial reporting. This position is responsible for ensuring the accuracy and compliance of financial data, assets, and liabilities within...
-
Senior Director of Accounting Operations
2 weeks ago
Irvine, California, United States Vaco Full timeJob SummaryWe are seeking a highly experienced and skilled Senior Director of Accounting Operations to join our team at Vaco. As a key member of our finance department, you will be responsible for overseeing the General Accounting function, including SOX Compliance and Financial Reporting. Your expertise will be instrumental in ensuring the accuracy and...
-
Regulatory Affairs Specialist
1 day ago
Irvine, California, United States Orion Group Full timeJob SummaryOrion Group is seeking a highly skilled Regulatory Affairs Specialist to support the development and implementation of the global regulatory strategy for company cosmetic and OTC products.The ideal candidate will have a strong understanding of personal care product industry regulatory affairs discipline throughout the product lifecycle, including...
-
Executive Director in Training
1 day ago
Irvine, California, United States Belmont Village Full timeBelmont Village Senior Living is seeking a highly motivated and experienced hospitality management professional to join our team as an Executive Director in Training. This comprehensive 12-month program will provide you with the skills and knowledge necessary to excel in a senior living executive director role.As an Executive Director in Training, you will...
-
Regulatory Compliance Specialist
4 days ago
Irvine, California, United States Gable Search Group Full timeJob Title: Regulatory Compliance SpecialistJob Summary:We are seeking a highly skilled Regulatory Compliance Specialist to join our team at Gable Search Group. The successful candidate will be responsible for providing guidance on regulatory requirements, assisting in regulatory-related projects, and ensuring compliance with FDA regulations, ISO standards,...
-
Operations Director
3 weeks ago
Irvine, California, United States Jobot Full timeJob SummaryAs the Operations Manager for Jobot, you will play a crucial role in overseeing and managing the operational aspects of the organization. Your primary responsibility will be to optimize efficiency, enhance productivity, and ensure seamless business operations across all departments.Key Responsibilities:Operations Management: Develop and implement...
-
Regulatory Affairs Specialist
1 week ago
Irvine, California, United States TalentBurst, an Inc 5000 company Full timeRegulatory Affairs Specialist Job DescriptionTalentBurst, an Inc 5000 company, is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for medical devices.Key Responsibilities:Compile and maintain regulatory...
-
Regulatory Affairs Specialist
3 weeks ago
Irvine, California, United States Fluxergy Full timeAbout UsFluxergy is a rapidly growing in vitro diagnostics company that is revolutionizing laboratory testing with its innovative multi-modal point-of-care platform. Our platform enables molecular, clinical chemistry, immunoassay, and hematology testing on the same system, making it a game-changer in the industry.Our MissionWe are seeking a highly motivated...
-
Network Operations Director
5 days ago
Irvine, California, United States Futran Tech Solutions Pvt. Ltd. Full timeDirector of Service OperationsFutran Tech Solutions Pvt. Ltd. is seeking a highly skilled Director of Service Operations to lead our network operations team. The ideal candidate will have a strong background in network infrastructure, security, and delivery, with excellent stakeholder management and team coordination capabilities.Key Responsibilities:Trend...