Regulatory Affairs Manager

A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-state area's most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since 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. This position is with my direct client Job Description Client: Direct Client Location: Wayne, PA Job Title: Regulatory Affairs Manager Duration: 6 Months+ Job Summary Responsible for managing and conducting US regional regulatory activities under supervision. Lead regulatory activities for assigned projects in line with US regulatory requirements. Primary Responsibilities Include Function as liaison between FDA and the company for assigned projects, with supervision as appropriate. Plan, coordinate, organize, and prepare high-quality regulatory submissions for assigned products, including pre-approval and post-marketing submissions. Ensure regulatory compliance for all responsibilities. Implement regulatory strategies for the development and maintenance of assigned products. Maintain up-to-date knowledge of FDA regulations, guidance documents, and ICH guidelines. Additional Responsibilities Prepare, review, and process regulatory submissions such as INDs, BLA, NDA, amendments, reports, protocols, reports, investigator brochures, and safety reports. Participate in project and regulatory teams, providing regulatory recommendations. Coordinate with other departments on regulatory documentation, ensuring standards and consistency. Conduct regulatory communications with FDA under supervision. Manage FDA meeting requests, preparations, and minutes. Qualifications Education and Experience: BA/B.S in a scientific, healthcare, or related field; advanced degree preferred. 5-10 years of biopharmaceutical experience in regulatory affairs and drug development. Knowledge of FDA regulations and drug approval processes. Strong communication skills. Key Skills Excellent written and verbal communication. Ability to collaborate effectively with internal teams and external organizations. Strong organizational skills, multitasking, and attention to detail. Ability to apply scientific principles to regulatory issues. Complexity and Problem Solving Execute regulatory strategies and develop submission timelines under supervision. Contribute to regulatory content development supporting company positions. Internal and External Contacts Function as liaison with FDA and coordinate with regulatory management and global regulatory leads. Represent US regulatory strategy in product teams. Interact with cross-functional teams on development issues. Feel free to forward this email to colleagues who might be interested. Additional Information Thanks!!! Warm Regards, Amrit Singh Clinical Recruiter Integrated Resources, Inc Tel: View phone number on click.appcast.io Fax: View phone number on click.appcast.io Inc. 5000 - 2007-2014 (8th Year) #J-18808-Ljbffr