Regulatory Affairs Associate Jobs

Role:

Clinical Regulatory Affairs Associate

Location:

Plano TX

Duration:

12 months contract with possible extensions

Description:

This position interacts with multiple departments, as appropriate, involved in regulatory submissions.

The position, under supervision of the manager, makes FDA submissions, reviews requisite/critical documents and reports for completeness and suitability for submission.

Specific Responsibilities Receive documents from various sources and review for completeness and suitability for submission to FDA.

Request missing and/or illegible pages, arrange for translations as needed.

Review regulatory documents to assure FDA requirements are met and are ready for submission

Responsible to handle the release and shipment of investigational drug supplies to the investigators participating in the clinical studies.

Including assuring the regulations and laws regarding IND submissions and financial disclosure meet compliance.

Assure CMC and QA have approved the product, and that the labeling of the product meets the regulations for interstate shipment.

Handle drug re-supplies for the above-mentioned studies.

Prepare 30-day investigator submissions

Gather information and prepare IND and NDA annual reports.

With the manager's guidance, prepares new IND, NDA and SNDA submissions, amendments and supplements.

Must have the following:

Needs to be able to organize and prioritize tasks and work independent of manager.

Be able to think of new and better ways to accomplish tasks

Direct temporary help in heavy work situations.

Work with all team members to accomplish tasks and be able to clearly communicate with the team.

needs to do writing for routine submissions.

Think of solutions to overcome problems in making submission goals.

Review submissions with a critical eye for typos, grammatical errors, pages out of order, etc.

Impact of Actions / Decisions -Within functional area:

This position is expected to review critical documents and handle routine submissions with little input from the manager.

With more complex tasks/submissions, work with the manager to accomplish goals/tasks.

Outside functional area:

Work with various functions to resolve any deficiencies.

Timely review of critical documents for drug release is expected.

Independent Judgment Will judge the adequacy of critical documents such as informed consent forms.

Will judge the adequacy of reports as far as completeness, legibility, need for translation.

About 50% or more of the judgments can/should is made independently at this position.

The rest are made with the concurrence or advice of the manager.

This position might require the management of temporary labor and supervise the assembly of submission, and verify that the documents meet the regulatory requirements.

Education Requirement:

Science (biology, chemistry etc.) preferred. (Or Equivalency, special qualifications, certifications, licenses, etc.)

Work experience:

Five plus years of work experience.

Understanding of scientific disciplines required.

Understanding of FDA regulations governing INDs, NDAs, GCPs, submission processes, submission content, and specific time requirements for various submissions desired.

Good computer skills required.