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Regulatory Submission Publisher

North Potomac, MD 20878

Posted: 10/26/2022 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.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet domain (@theplanetgroup.com, @theplanetforward.com, @planet-technology.com, @planet-pro.com, @planetinteractive.com, @pfes.com, @launchcg.com, @planet-pharma.com, @planet-healthcare.com) - and not a domain with an alternative extension like .net, .org or .jobs.

The Planet Group and our companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About North Potomac, MD

Ready to jumpstart your career in the vibrant North Potomac, Maryland area? This charming region, nestled in Montgomery County, is a hidden gem offering job seekers a unique blend of urban amenities and serene natural beauty. With its proximity to the bustling city of Washington, D.C., North Potomac provides an ideal balance for professionals seeking growth opportunities without sacrificing quality of life. Enjoy exploring the nearby Great Falls Park or catch a show at the Strathmore Concert Hall. Indulge in the diverse cuisine along River Road or take a leisurely stroll through the local art galleries. Whether you're into sports, arts, or outdoor activities, North Potomac has something for everyone. Check out our job listings today and discover the exciting career opportunities waiting for you in this enchanting Maryland locale.
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