Regulatory Affairs Senior Associate

7 days ago

Thousand Oaks, United States Aditi Consulting Full time
Description:
Administrative projects as backup support of Operations staff during project period. Assist US Promotion Regulatory Representatives to support US Promotion Regulatory activities (e.g. Abbreviated Reviews and system updates for label changes, Regulatory Information Management (RIM) archiving and other process documentation authoring support, Veeva data entry and collection). Create and maintain records in Veeva and SharePoint. Appropriately archive all regulatory documents and agency communications per process regulatory documentation (e.g. Preclearance & Request for Advisory Comments (RFAC) submissions and other FDA communications). Ability to lead and manage Webex meetings and provide meeting minutes.

Performance Factors:
  • Relationships with Others: The employee works effectively and relates well with others including superiors, colleagues, and individuals inside and outside the Company. The employee exhibits a professional manner in dealing with others and works, to maintain constructive working relationships.
  • Communication and Contact: The employee communicates effectively both verbally and in writing with superiors, colleagues, and individuals inside and outside the Company.
  • Dependability: The employee can be depended on to complete work in a timely, accurate, and thorough manner and is conscientious about assignments.
  • Ability to read and understand written instructions and follow documented process independently
  • Proactively handling tasks by monitoring upcoming activities or assisting with daily team workload responsibilities

Qualifications:
  • Strong business communication and organization skills
  • Detail oriented
  • MS-Office applications
  • Tableau (preferred)
  • Visio
  • Veeva Promo Mats
  • Regulatory experience
  • Copy editing
  • Technical writing
  • Project Management

Top 3 Must Have Skill Sets:
  • Veeva system experience for both PromoMats and Regulatory Information Management (RIM) vaults.
  • Project managing experience by proactively handling tasks by monitoring upcoming activities or assisting with daily team workload responsibilities and ability to read and understand written instructions and follow documented process independently.
  • Create PowerPoint, Visio, manipulate data in Excel spreadsheets (including pivot tables) and author/update MSWord documents and Creation of Infographics, slides, technical editing of process documents, and proofreading.

Day to Day Responsibilities:
  • Assist US Promotion Regulatory Representatives to support US Promotion Regulatory activities (e.g. Abbreviated Reviews and system updates for label changes, Regulatory Information Management (RIM) archiving and other process documentation authoring support, Veeva data entry and collection). Create and maintain records in Veeva and SharePoint.
  • Appropriately archive all regulatory documents and agency communications per process regulatory documentation (e.g. Preclearance & Request for Advisory Comments (RFAC) submissions and other FDA communications).
  • Ability to lead and manage Webex meetings and provide meeting minutes.

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.

#AditiConsulting

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