Regulatory Affairs CMC Project Manager

Integrated Resources Inc.; Lexington (KY); On-site; USD 75,000 - 95,000; Full time

Job summary

Integrated Resources Inc. is seeking a project manager to handle multiple global submissions in compliance with health regulations. The ideal candidate will possess a professional degree and experience in project management, showcasing excellent communication and organizational skills. This role involves coordinating internal and external interactions to meet project timelines effectively.

Qualifications

• Professional Degree along with regulatory coursework preferred.
• Experience with MS Office and electronic systems is highly desirable.

Responsibilities

• Manage global submissions to ensure timely completion.
• Create project plans with timelines and monitor key deliverables.
• Work independently and manage concurrent projects.

Skills

Communication

Project Management

Attention to Detail

Education

Professional Degree (Chemistry, Biology, Biochemistry, Pharmacy)

Regulatory related coursework

Tools

MS Office

Databases and electronic systems

Job description

A Few Words About UsIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

Manages multiple multi-product CMC focus global submission to ensure timely completion per established timelines. In consideration of health authority requests & program plans, create project plans with documentation requirements, timelines, and identified and monitor activities of key deliverables. Will work closely with project leads, but require the ability to work independently with minimal supervision. Requires excellent verbal and written communication skills, must be able to manage concurrent projects that may be unplanned, detailed oriented, and organized. May require internal and external interactions in support of project plans.

Qualifications

Education Skills:

Professional Degree and/or coursework (Chemistry, Biology, Biochemistry, Pharmacy, etc) and at least one year of regulatory related course work is preferred.

Proficient in MS Office and experience in databases and electronic system is highly desirable.