Clinical Regulatory Affairs Associate

For further inquiries regarding the following opportunity, please contact one of our Talent Specialists

Meghna at 224 369 4230

Sony at 630 847 1417

Title: Clinical Regulatory Affairs Associate

Duration: 1 Year

Location: Plano, TX

Description:

This position is NonExempt.

Hours over 40 will be paid at Time and a Half. 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.

WHAT YOU’LL DO

• Prepares robust regulatory applications for Class II or Class III devices (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives.
• Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
• Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. Provides guidance and expertise.
• Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
• Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
• May interface directly with FDA and other regulatory agencies.
• Work with cross-functional team to support product release process.
• Reviews protocols and reports to support regulatory submissions.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

• BA or BS degree in a technical discipline
• 1+ years regulatory experience
• Experience with either 510(k) applications, PMA supplements and US device regulations or with EU and other international medical device regulations and submissions.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to critically think through complex problem statements.

Preferred

• Experience writing clear and concise technical documents.
• Ability to work in a highly matrixed and geographically diverse business environment, unit model.
• Ability to work in a broader enterprise/cross-division business
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.

Job Type: Contract

Pay: $32.00 - $34.50 per hour

Benefits:

• Dental insurance
• Health insurance
• Life insurance
• Referral program

Schedule:

• Monday to Friday

Application Question(s):

• Do you have Five plus years of work experience in Clinical Regulatory Affairs?
• Do you have an understanding of scientific disciplines and FDA regulations governing INDs, NDAs, GCPs?

Work Location: In person

Speak with the employer
+91 630 847 1417