About this opportunity
Integrated Resources Inc. lists this Regulatory Affairs Manager opportunity in wayne, Pennsylvania. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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.
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Additional Information
Thanks!!!
Warm Regards,
Amrit Singh
Clinical Recruiter
Integrated Resources, Inc
Tel:
Fax:
Inc. 5000 - (8th Year)
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Worksite address
wayne, PA, 19087, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.