The Planet Group
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http://www.theplanetgroup.com
http://www.theplanetgroup.com
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Primary Responsibilities:
Essential Requirements:
Regulatory Submission Publisher
101 Orchard Ridge Dr North Potomac, MD 20878 US
Posted: 10/26/2022
2022-10-26
2022-11-27
Employment Type:
Contract
Job Number: 515116-1
Country: United States
Is job remote?: Yes
Job Description
Primary Responsibilities:
- Prepares/agrees/executes global/regulatory tactical submission plans for allocated project/prod that implement the agreed regulatory strategy to develop and maintain products. Provides independent tactical/scientifically related guidance cross functional on aspects of regulatory affairs.
- Uses knowledge and experience in the regulatory field to influence functional objectives.
- The ROM is an expert in end-to-end document and submission publishing.
- The ROM is also experienced in understanding requirements regarding the technical aspects of global regulatory submission publishing and dispatch to global Health Authorities.
Essential Requirements:
- Super accelerated Submissions
- Experience as a document and submission publisher including knowledge of regulatory publishing tools, planning, preparation, and delivery of regulatory submissions throughout the product's life cycle across multiple markets
- Ability to provide global expertise on requirements for electronic document management and document (report level) publishing.
- Demonstrated ability to work collaboratively in a global team environment and to have good project management and time management skills
- A broad working knowledge of process improvement methodologies, tools, techniques and their application.
- A practical understanding and application of building/maintaining relationships with drug project team members
- Successful application of customer service level agreements
- The ability to manage routine quality, resource and performance issues to resolution.
- To work independently and to set and manage priorities, resources, performance targets and project objectives in a global environment.
- Ability to assess data, documentation, and processes for regulatory impact/compliance with relevant regulations and guidance, and clearly communicate requirements to immediate stakeholders.
- Ability to apply project management principles and techniques.
- Excellent English (written and verbal) communication skills.
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