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8 jobs that use Regulatory Submissions the most

Jobs that use regulatory submissions the most include biostatistics director, regulatory affairs associate, and medical scientist.

What jobs use Regulatory Submissions the most?

1. Biostatistics Director

How biostatistics director uses Regulatory Submissions:

  • Act as project director for managing the preparation of safety and efficacy reports for NDA submission.
  • Support electronic regulatory submission which include STDM, CDISC standards.
  • Create and maintain standard QC notebooks for clinical research studies.

Most common skills for biostatistics director:

  • SAS
  • CRO
  • Regulatory Submissions
  • Study Design
  • Biometrics
  • Statistical Analysis

2. Regulatory Affairs Associate

How regulatory affairs associate uses Regulatory Submissions:

  • Manage CQA vendor deliverables and liaise with vendors to identify and remedy GCP compliance issues with active sites.
  • Manage the compliance education tracking and documentation process for international GMP education.
  • Manage eCTD submission preparation by negotiating data requirements and deliverable dates with internal technical teams.

Most common skills for regulatory affairs associate:

  • Regulatory Affairs
  • FDA
  • Regulatory Submissions
  • Medical Devices
  • Global Regulatory
  • Regulatory Agencies

3. Medical Scientist

How medical scientist uses Regulatory Submissions:

  • Manage clinical monitors in successful completion of large international hypertension study.
  • Conduct technology comparison study to assess applicability of a wide range of chromatography products to support specific HTS assays.
  • Analyze parallel synthesis libraries using high-throughput LC/MS methods with UV/ELS detection including mass determination, purity evaluation, and quantification.

Most common skills for medical scientist:

  • Clinical Trials
  • Regulatory Submissions
  • Advisory Boards
  • Risk Management
  • External Stakeholders
  • Medical Writing

4. Scientific Writer

How scientific writer uses Regulatory Submissions:

  • Manage, and assist in the recruiting activities of, CRO resources preparing regulatory documents on behalf of APGD.
  • Harmonize USP and EP methods.
  • Exhibit proficiency in researching, writing, editing, and proofreading.

Most common skills for scientific writer:

  • IND
  • NDA
  • Abstracts
  • Regulatory Submissions
  • Proofreading
  • Clinical Study Reports

5. Senior Staff Scientist

How senior staff scientist uses Regulatory Submissions:

  • Manage pediatric dose development project, technology transfer project and alternate API supplier qualification project on budget and on schedule
  • Conduct research and analyze data to identify potential biomarkers and provide input for selection of candidates for non-clinical studies development.
  • Establish methods for OTFT parameters extraction, physics-base device modeling, and circuit elements simulation.

Most common skills for senior staff scientist:

  • Data Analysis
  • FDA
  • Next-Generation Sequencing
  • Statistical Analysis
  • Regulatory Submissions
  • PK

6. Regulatory Specialist

How regulatory specialist uses Regulatory Submissions:

  • Utilize the``SharePoint"system to manage the document change control process and maintain configuration control.
  • Manage and submit regulatory permit and notification applications to USDA to import, move and release regulate plant materials.
  • Assess study results for adherence to 40 CFR EPA regulatory requirements.

Most common skills for regulatory specialist:

  • FDA
  • Regulatory Compliance
  • Regulatory Agencies
  • Regulatory Submissions
  • Customer Service
  • Clinical Trials

7. Regulatory Affairs Manager

How regulatory affairs manager uses Regulatory Submissions:

  • Implement and achieve ISO 9001 and ISO 13485 registrations for the first time for the company.
  • Manage team which monitor the clinics' daily, weekly and monthly water and equipment maintenance requirements to meet CMS regulations.
  • Manage departmental and special project economics, including oversight of budgeting, expense management, and reimbursement billing.

Most common skills for regulatory affairs manager:

  • Regulatory Affairs
  • FDA
  • Medical Devices
  • Regulatory Submissions
  • Regulatory Agencies
  • Global Regulatory

8. Public Affairs Internship

How public affairs internship uses Regulatory Submissions:

  • Manage official MDA YouTube and Flickr channels.
  • Post daily email traffic alerts and manage Facebook content.
  • Manage alumni database, and communication with other departments and alumni.

Most common skills for public affairs internship:

  • Public Affairs
  • Press Releases
  • PowerPoint
  • Public Policy
  • Regulatory Submissions
  • Community Outreach

Other skills