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Regulatory Affairs Senior Associate

1 month ago

Thousand Oaks, United States Aditi Consulting Full time
Summary:
In order to support our team's ongoing projects, we are seeking a candidate who is comfortable with learning new systems, has experience managing content in SharePoint, has working experience with the Six Sigma methodology, process mapping and project management experience.

This will be a 100% remote role. Our team is looking for a candidate who is able to work standard hours (ex. 7a-4p or 8am-5p etc.), with EST time zone preferred. The candidate would need to have flexibility to shift their hours to start and end their day at a later time, if additional support is needed for the PST time zone.

Day to Day Responsibilities:
  • Works well collaboratively.
  • Detail oriented
  • Comfortable learning new systems/processes.
  • Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives.
  • Work with stakeholders to gather requirements and develop solutions
  • Provide Subject Matter Expertise in Veeva Vault Configuration and Regulatory Processes to a global user base.
  • Develop and deliver training materials and presentations to a global audience.
  • Author/review/approve quality Regulatory Information Management & Systems documents
  • Analysis of the existing documentation and process explore avenues to simplify and streamline.
  • Provide operational support for Regulatory Data Management, Submissions, and EU CTR.
  • Develop and implement process improvements and automation.
  • Lead and/or support team projects
  • Organize and present data in user-friendly, graphical, interactive informational summaries that illustrate how GRAAS is performing and allow us to understand and improve business performance
  • Utilize the Six Sigma method to support team processes

Top 3 Must Have Skill Sets:
  • Good communication skills (verbal & written)
  • Resourceful critical thinker
  • Experience in process mapping and detail/data quality focused
  • Regulatory Affairs understanding highly preferred
  • Any regulatory certifications (RAC) is desirable
  • Interest in technical aspects of systems i.e. SQLs etc. will also be considered

Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate's qualifications, skills, competencies, experience, location and end client requirements).

Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.

Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.