Regulatory Operations Specialist II

Job Overview

Responsible to provide analytical support for the developmental projects / comparative dissolution projects received from other client sites.

Summary Of Responsibilities

These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties as individual contributor globally.

• Responsible to provide analytical support for the developmental projects / comparative dissolution projects received from other client sites.
• Responsible to be an interface with contract laboratories, suppliers, customers and peers to define and improve project performance and expectations.
• Responsible for to coordinate with CRO and ensure that project complete with in timeline.
• Designs scientific experiments. Actively and personally monitor lab work. Recommends expansion or curtailment of investigations on the basis of experimental results or scientific information.
• Responsible for the preparation of test methods, technical documents, protocols and reports whenever required
• Is responsible for the proper recording of information. Ensures that records and raw data are properly retained. Summarizes, interprets, reviews data and draws conclusions.
• Analyzing and drawing interpretation out of the dissolution data sets.
• Trouble shooting the problems associated with instruments or method
• Performing activities following the GMP / safety requirements related to the assigned activity.
• Knowledge of In vitro dissolution testing
• Comparative dissolution testing including multimedia dissolution
• Interface with Contract labs
• Dissolution Investigations.
• Basic knowledge on formulation (Oral solid dosage forms)

Qualifications (Minimum Required)

Experience (Minimum Required)

Preferred Qualifications Include

Work Environment

Learn more about our EEO & Accommodations request here.

Skills Required

Microsoft Office Suite