Regulatory Affairs Manager
6 days ago
We are seeking a highly skilled Regulatory Project Manager to join our team at Precigen, Inc. in Germantown, Maryland.
This is an exciting opportunity for a motivated and organized individual to support complex filing activities, ensuring compliance with technical and regulatory standards.
The successful candidate will be responsible for developing and managing submission content plans, monitoring deliverable progress, and conducting regular project meetings with senior leadership and stakeholders.
Key responsibilities include:
- Developing and managing submission content plans, including timelines and resources, to ensure projects are completed on time and within scope.
- Monitoring and tracking deliverable progress, identifying potential risks, and developing mitigation strategies.
- Conducting regular project meetings and providing updates on status, issues, and changes to senior leadership and stakeholders.
- Ensuring regulatory reporting and documentation requirements are met, including the development of reports, presentations, and updates.
The estimated salary for this role is $110,000-$140,000 per year, based on industry standards and location.
To be successful in this role, you will need a strong knowledge-base of eCTD requirements, ICH guidelines, and FDA guidance documents, as well as experience working in global environments and interdisciplinary teams.
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Project Management Specialist
6 days ago
Germantown, Maryland, United States Precigen, Inc Full timeJob DescriptionPrecigen, Inc. is seeking a Regulatory Project Manager to support our Regulatory Affairs team in Germantown, Maryland.The successful candidate will be responsible for supporting complex filing activities, ensuring compliance with technical and regulatory standards, and coordinating submission planning and timelines with internal publishers and...
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Compliance and Regulatory Specialist
6 days ago
Germantown, Maryland, United States Precigen, Inc Full timeAbout the Role:Precigen, Inc. is a leading biotechnology company seeking a talented Regulatory Affairs Manager to join our team in Germantown, Maryland. The successful candidate will be responsible for ensuring compliance with technical and regulatory standards, and providing strategic thinking, efficient resource management, and clear communication with...
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Project Lead
6 days ago
Germantown, Maryland, United States Precigen, Inc Full timeJob Description:We are seeking a skilled Regulatory Affairs Manager to join our team at Precigen, Inc. in Germantown, Maryland. This role involves strategic thinking, efficient resource management, and clear communication with stakeholders and the project team.Key Responsibilities:Develop and manage submission content plans, including timelines and...
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Accounting Operations Manager
1 week ago
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Thermoforming Quality Assurance Manager
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Financial Operations Manager
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Financial Operations Manager
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GMP Materials Management Associate
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Cell Therapy Stability Management Expert
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Medication Therapy Professional
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Clinical Team Lead
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Senior Accounting Lead
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Germantown, Maryland, United States Addison Group Full timeAbout Our ClientA leading provider of professional services is looking for a highly skilled Senior Accounting Consultant to join their team in Germantown, MD. The ideal candidate will have at least 8 years of experience in accounting, preferably within the government contracting sector, and expertise in Deltek CostPoint (version 8).The Senior Accounting...
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Senior Accountant Associate
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Germantown, Maryland, United States uBriGene Biosciences Full timeJob Summary:">We are seeking a Senior Accountant Associate to join our team in Germantown, MD. As a Senior Accountant Associate, you will play a key role in managing financial operations, preparing financial statements, and ensuring compliance with GAAP and regulatory requirements.Responsibilities:">Manage accounts payable, accounts receivable, and general...
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Accounting Professional
1 week ago
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Senior Costpoint Consultant
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Senior Financial Analyst
1 month ago
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Germantown, Maryland, United States SC&A Inc Full timeAbout SC&A Inc.SC&A Inc is a small business focused on environmental consulting services to federal, state, and local government agencies and the private sector. Our areas of expertise include environment, health, and safety; radiological and nuclear safety and security; climate adaptation; air quality; and emergency management and preparedness.Job...