Job Description

Regulatory Information Management (RIM) Consultant
Job Number: 21-05073
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Regulatory Information Management (RIM) Consultant for our client in Lawrenceville, NJ. 
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Position Overview:
  • The RIM contractor is accountable to enter and manage regulatory information (RIM) for submissions, approvals and associated product data.
  • They create and monitor CMC change control for commercial and investigational product.
  • Create submission content plan to feed in the DCN for CS portal maintenance as well as creating CMC information records to capture new submitted and approved CMC updates for all impacted fields in the RIM tool.
  • Function as a strong RIM user, interact with global regulatory associates, address questions and solve problems.
  • Monitor data quality, accuracy and integrity. Participate in system testing for upgrades by executing scripts and being involved in validation.
 
Responsibilities:
  • Maintains good understanding of the assigned regulatory processes with specific areas of expertise
  • Manages daily workload and independently addresses questions for assigned regulatory processes
  • Contributes to and helps identify system and process gaps in developed areas of expertise
  • Provides support for internal audits, HA inspections and may be asked to contribute to the resolution of corrective preventive action plans in defined area of expertise
  • At the request of management, prepares data in supports of meetings as they related to developed areas of expertise
  • Recognizes and reports data compliance issues, and is able to derive how they impact assigned processes and other processes
  • Executes operational aspects of assigned regulatory processes according to procedures
 
Qualifications:
  • Degree Requirements: BS/BA in a relevant scientific or technical field preferred.
  • Additional experience may be considered in lieu of a degree
  • Experience Requirements: Minimum of 3 years of relevant experience
 
Required Skills:
  • Demonstrates critical thinking skills and the ability to apply this to daily workload decisions
  • Demonstrates awareness of the procedures and decision-making process of relevant Health Authorities.
  • Strong understanding of regulatory operations
  • Knowledge of computer systems in an R&D environment
  • Basic understanding of electronic records management rules
  • Participates in projects and communicates and interacts with internal customers
  • Practical experience with desktop application software suites
  • Proficient in the English language both written and oral, and able to communicate effectively in written form with non-English speakers.
  • Good presentation skills.
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
John Bayog
John.Bayog@eclaro.com
6466952925
John Bayog | LinkedIn
 
Equal Opportunity Employer:
Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Application Instructions

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